A Classic Study: The lung Health Study

Every now and again I like to pick one of the classic research studies on smoking cessation in order to highlight some of the key findings. Today I’m going to focus on the part of the Lung Health Study.

The Lung Health Study is certainly one of the best smoking cessation studies ever carried out, partly because of the comprehensive nature of the assessment and follow-up of its 5,887 participants and partly because it was way ahead of its time in delivering a truly “state-of-the-art” intensive smoking cessation intervention which was compared in a randomized manner to the effects of “usual care”. The Lung Health Study (LHS) was a randomized clinical trial of smoking cessation and inhaled bronchodilator therapy in smokers 35 to 60 years of age who did not consider themselves ill but had evidence of mild to moderate airway obstruction. Almost 4,000 of the participants were randomly allocated to receive a very intensive smoking cessation intervention consisting of group treatment (12 group meetings over 10 weeks), combined with aggressive use of nicotine gum. Patients’ partners were also allowed to attend for treatment, patients were encouraged to attend for retreatment if they did not quit, and were provided with ongoing relapse prevention over the 5 years of the study. They were also encouraged to continue using the nicotine gum for as long as it was helpful, and to use it even if still smoking in order to get quit. This excellent intervention resulted in 35% quit rates at the end of the first year and 22% remained sustained quitters at 5 year follow-up (compared to 9% and 5% in the “usual care” group.

This cohort was followed up for 15 years and dozens of excellent research papers have been published describing the health effects and the factors associated with quitting smoking. But one of the key results was that when they did the 15 year follow up they found that significantly more people who had been randomized to receive the smoking cessation intervention were still alive, as compared to those who were randomized to “usual medical care”. At face value this may not sound so surprising but unlike most studies of smoking and mortality this was based on analysis of a randomization to smoking-cessation treatment versus no treatment and shows that those getting smoking cessation treatment had better survival, even though the long term sustained quit rate was only 22%. So if you want proof that intensive smoking cessation treatment saves lives, this is the study that proves it.
The authors of the study estimated that the unit cost for providing the smoking cessation treatment and relapse prevention program in this study was $2,000 per patient. In comparison to almost every other healthcare intervention, this is incredibly good value for a life-saving intervention. Just for comparison, the Tobacco Dependence Clinic at UMDNJ-School of Public Health tries to provide a similarly intensive treatment for over 500 new patients per year on $102,000 of funding (i.e. $200 per patient). Although I feel that a unit cost in the range of $500-$2000 is more realistic when all the costs are included, this shows that quality smoking cessation treatment, similar to that provided in the Lung Health Study, can be provided relatively efficiently outside of a research context.

The Lung Health Study provides an excellent guide to providing quality smoking cessation treatment and the health outcomes that can be obtained.

Anthonisen NR, Skeans MA, Wise RA, Manfreda J, Kanner RE, Connett JE; Lung
Health Study Research Group. The effects of a smoking cessation intervention on
14.5-year mortality: a randomized clinical trial. Ann Intern Med. 2005 Feb
15;142(4):233-9.

Anthonisen NR, Connett JE, Kiley JP, Altose MD, Bailey WC, Buist AS, Conway WA
Jr, Enright PL, Kanner RE, O'Hara P, et al. Effects of smoking intervention and
the use of an inhaled anticholinergic bronchodilator on the rate of decline of
FEV1. The Lung Health Study. JAMA. 1994 Nov 16;272(19):1497-505.

Foulds J, Gandhi KK, Steinberg MB, Richardson D, Williams J, Burke M, Rhoads GG. Factors associated with quitting smoking at a tobacco dependence treatment clinic. American Journal of Health Behavior 2006; 30:400-412

Labels: cessation, cigarette smoking, jonathan foulds, Lung Health Study, mortality, nicotine dependence treatment, tobacco dependence treatment

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Menthol: it helps the poison go down easier

I’m writing from the second conference on menthol and cigarettes, in Washington DC. This conference was organized to review the evidence on the effects of menthol in cigarettes and to discuss what further research is necessary and what actions should be taken.

To me, the presentations appeared to suggest that right now the evidence that menthol cigarettes are more harmful to health is weak. However, the evidence that menthol cigarettes are a starter product for youth and that menthol cigarettes can (under certain circumstances) be more addictive and harder to quit, is quite strong and getting stronger all the time.

My own presentation focused on data we have previously published (and that I’ve already discussed on this blog) showing that menthol cigarettes are harder to quit for African Americans, Latinos and for people on a low income. It was very fortunate that just yesterday a new study by colleagues at UMDNJ-School of Public Health came into the public domain and so I was able to discuss its findings.

I think that study, by Drs Dan Gundersen, Cris Delnevo and Olivia Wackowski, is a very important one. The paper, which will be published in the journal “Preventive Medicine” and appeared online yesterday, was based on the 2005 National Health Interview Survey. It focused on a representative sample of U.S. adult ever exclusive cigarette smokers who had ever tried to quit (n=7,815). It aimed to assess whether people who were primarily menthol smokers had a lower quit rate than people who were regular cigarette smokers (after adjusting for other characteristics of those groups). The study found that among African American and Hispanic smokers, those who smoke menthols have a significantly lower rate of quitting. Interestingly it found that among whites, there was an opposite effect, with white menthol smokers having a slightly higher quit rate than white regular cigarette smokers.

One of the pleasing parts for me about this study was that the results, in a representative sample of smokers who had tried to quit, were almost perfectly consistent with the results we had previously published based on people trying to quit at our smokers clinic (Gandhi et al, 2009). Like our clinic study, this new paper found that the effect of menthol on inhibiting smoking cessation is a sizeable one. For example, among African Americans, while 62% of regular cigarette smokers successfully quit, only 44% of menthol smokers were able to quit. Also like our clinic study, the effect remained significant after controlling for differences in the relevant characteristics of those who smoke regulars and menthols. Also like our clinic study, the menthol effect differed between white (non-Hispanic) smokers and minority smokers. But one thing that was different was that Dr Gundersen’s study found that white menthol smokers were actually MORE likely to quit than white non-menthol smokers. So the question remains, why the difference of effect of menthol on quitting smoking between whites and minorities?

I remain convinced that the underlying mechanism of action of menthol is to enable smokers to inhale more nicotine (and smoke) under circumstances that require it. The main circumstance requiring the smoker to inhale more nicotine per cigarette is a situation forcing the smoker to reduce their daily cigarette consumption. There are various forces requiring smokers to reduce their cigarette consumption, but a major one is money. In recent times as cigarettes have become more expensive across the United States, many smokers can no longer afford to smoke a pack a day. So they have to reduce to 5 or 10 cigarettes per day or try to quit. Of course we know that as smokers reduce, they rend to inhale more nicotine per cigarette (an effect often referred to as “nicotine compensation”). But inhaling more smoke per cigarette can cause harsh sensations in the throat. Menthol cools that effect, making it easier for larger doses of the poison to go down (Williams et al, 2007). But one of the effects of inhaling a higher dose of nicotine per cigarette is that each cigarette becomes more reinforcing and addictive. Although there is always more than one explanation for any effect, I believe that facilitation of increased nicotine inhalation is one of the main effects of menthol. But people who have plenty of money don’t need to smoke fewer each day, and inhale more from each one. So there is a socioeconomic difference in the effect. This is part of the reason for the difference of effect of menthol in whites and minorities. In our clinic study we found a similar menthol effect in unemployed whites that we did in employed African Americans (with no effect of menthol on quitting at all in employed whites).

I suspect that if national data is analyzed focusing on unemployed white smokers living in the north east of the U.S. (the highest cigarette cost area), who tried to quit in recent times (when high cigarette taxes kicked in), we would find a lower quit rate among the menthol than the non-menthol smokers in that group.

In terms of harms to health, we’d more easily find these in the short term by looking, for example, at pregnancy outcomes in menthol versus non-menthol smokers. I’m suggesting greater study of the effects of menthol in pregnancy because it’s a situation when many smokers try to cut down or quit, but many remain smoking, and in which the health impact can be measured in the short term (e.g. birth weight and complications).

I’m leaving this conference with a greater clarity that menthol added to cigarettes make it easier for young people to start smoking and harder for smokers to quit, because menthol helps the poison go down easier.


References

Gundersen D, Delnevo C, Wackowski O. Exploring the relationship between race/ethnicity, menthol smoking, and cessation, in a nationally representative sample of adults. Preventive Medicine (2009), doi:10.1016/j.ypmed.2009.10.003

Gandhi KK, Foulds J, Steinberg MB, Lou SE, Williams J. Lower quit rates among menthol cigarette smokers at a tobacco treatment clinic. International Journal of Clinical Practice 2009 Mar;63(3):360-7.

Williams JM, Gandhi KK, Steinberg ML, Foulds J, Ziedonis DM, Benowitz NL. Higher nicotine and carbon monoxide levels in menthol cigarette smokers with and without schizophrenia. Nicotine Tob Res. 2007 Aug;9(8):873-81.

Labels: African American, cessation, cigarette, ethnicity, Gundersen, Hispanic, jonathan foulds, latino, menthol, NHIS, race, Smoking, white

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Debunking myths about self-quitting (1989): a classic study.

Every now and again I’d like to pick a classic research study from the past which shaped our understanding of smoking cessation. Today I’m going to focus on a paper by Dr Sheldon Cohen and 16 other researchers (recognized experts in the field 20 years later) entitled “Debunking myths about self-quitting. Evidence from 10 prospective studies of persons who attempt to quit smoking by themselves.”

The study was conducted because a prior paper, based on a small number of people (161) had suggested that people who quit on their own are generally quite successful (more so than people who go for professional treatment) and that heavy smokers were just as likely to quit successfully on their own as light smokers. The researchers decided to pool together the data from 10 larger studies of “self-quitters” (smokers making a quit attempt without receiving any formal treatment), in order to get to the truth on these questions.

They picked 10 “prospective” self-quitting studies that followed people up for at least 6 months (most were at least 12 months) and that provided biochemical or other verification of people’s claim to have quit. Using prospective studies avoids the self-selection and recall biases you get when you simply recruit a group of people and ask them what it was like for them when they tried to quit. The 10 studies had taken place all over the country and included over 5,000 smokers and so this was thought more likely to provide results that would be generalizable to the population of smokers trying to quit on their own in the United States. One other good aspect of this study was that it included different measures of quitting, and assessed outcomes at numerous time points, enabling an analysis of both continuous “not a puff” quitting after a single attempt, as well as long term “point prevalence” abstinence, that may be the result of repeated quits and relapses over time.

The median “not a puff” continuous quit rate a year later was 4.2% and the median “point prevalence, not smoked in the past week” quit rate at 12 months was 14%. Those who tried to quit completely on their own, and those who had a manual to help them had similar quit rates. The study also found that heavy smokers (those smoking over a pack a day) were less than half as likely to quit for a year as less heavy smokers (a pack per day or less).

The study examined whether the number of previous quit attempts predicted the likelihood of successful quitting on this quit attempt. It found that although those who had never tried to quit before had slightly lower quit rates, there was no significant relationship between the number of prior quit attempts and success this time. A substantial proportion (24%) of those who had quit at 6 months had relapsed back to smoking by 12 months.

So this study was successful in debunking a number of myths about quitting smoking that were prevalent at the time. It showed that smokers who simply try to quit on their own with no assistance, do not (as had been claimed, and is still sometimes claimed) have surprisingly high quit rate. In this study the one year quit rates were in the range 4-14% depending on your definition. It also showed that quit rates vary by simple measures of baseline ‘dependence,” with heavier smokers having lower quit rates than less heavy smokers. It also found that the number of previous quit attempts has relatively little influence on a smoker’s chances of successfully quitting on the next quit attempt. Finally the study showed that a substantial proportion of smokers (around a quarter) who quit for 6 months, are likely to relapse in the next 6 months. One of the main conclusions of the study was that, “quitting smoking (by oneself or with the aid of a program) should be viewed as a process and not as a discrete event.” Wise words.

20 years later, even although the core findings from this study have been replicated many times, we still hear some of the myths about quitting smoking being repeated. The classic mistake (which resulted in the small study that prompted this one) is to try to figure out how people quit by asking a handful of successful self-quitters what it was like for them. Don’t be surprised if they tell you that the last time (i.e. the successful one, so far) wasn’t too hard. But that would be missing out on data from the other 95% of quit attempts that were not successful.

Reference
Cohen S, Lichtenstein E, Prochaska JO, Rossi JS, Gritz ER, Carr CR, Orleans CT, Schoenbach VJ, Biener L, Abrams D, et al. Debunking myths about self-quitting. Evidence from 10 prospective studies of persons who attempt to quit smoking by themselves. Am Psychol. 1989 Nov;44(11):1355-65.

Labels: cessation, classic, jonathan foulds, myths, self-quitting, Sheldon Cohen, Smoking, unassisted

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Help for young smokeless tobacco users: mylastdip.com

A month ago I wrote about the health risks from using smokeless tobacco:
http://www.healthline.com/blogs/smoking_cessation/2009/08/how-harmful-is-snuff-smokeless-tobacco.html

Today I’d like to mention a relatively new website that is designed to help young smokeless tobacco users (aged 14-25) to quit using smokeless tobacco, and to participate in a national cancer Institute-funded study of the usefulness of the site.
The website is called Mylastdip.com and was launched in October 2008. Over 500 people have enrolled on the site to take part in a free self-help quitting program. To enroll, participants must have an active e-mail address and be willing to complete some online questionnaires as part of the research program.
MyLasDip.com is free and available 24 hours a day, was developed by experts in smokeless tobacco cessation, and is based on methods that have been effective with thousands of smokeless tobacco users.

So check out: mylastdip.com

Labels: cessation, jonathan foulds, mylastdip.com, smokeless, tobacco

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Smoking after cancer diagnosis: Comment by Patrick Swayze’s doctor on CNN’s Larry King

Many people were saddened to hear of the recent death of the actor Patrick Swayze, after an almost two year battle with pancreatic cancer. Patrick Swayze was a very successful actor, most noted for his leading roles in the hit movies, Ghost and Dirty Dancing.

Within the past week, one of Patrick Swayze’s oncologists, Dr George Fisher, was interviewed on the CNN “Larry King Live” show and made the following comments:

LARRY KING: “He continued to smoke. Was that a bad idea?”

DR. GEORGE A. FISHER, ONCOLOGIST, STANFORD HOSPITAL & CLINICS: “I think at the point that one is already diagnosed with cancer, there's little additional harm in it. And if it -- it seems to provide him some comfort or partly identity of who he is, I certainly have no objections to that. But he would be the first to say that if you don't smoke, don't start. And if you do smoke, quit before you develop cancer.”

I suspect that Dr Fisher’s comments were referring to the specific context of someone suffering from a severe type of terminal cancer where the estimated life expectancy is in months rather than years, and not referring to all cancer diagnoses. So I think it is important that people, and particularly those people with a recent cancer diagnosis who are still smoking or recently quit, don’t take this comment out of context. Nowadays many types of cancer can be cured or effectively managed over a period of many years, and it is very clear that for many of these cancer diagnoses, the prognosis is much better if the patient quits smoking.

Below is a quote from a published review by an expert on this subject, Professor Ellen Gritz, of MD Anderson Cancer Center:
“The detrimental effect of smoking on cancer survival rates has been consistently demonstrated. Continued smoking after diagnosis has been found to negatively affect overall survival in patients with lung, head and neck, prostate, and cervical cancers. However, stopping smoking before diagnosis and treatment can have a positive influence on survival rates. Studies have generally indicated that the longer the interval between smoking cessation and initiation of cancer treatment, the better the prognosis.“

(Gritz ER, Fingeret MC, Vidrine DJ, Lazev AB, Mehta NV, Reece GP. Successes and failures of the teachable moment: smoking cessation in cancer patients. Cancer. 2006;106:17–27.)

Just last month the results of a very large study were published showing better outcomes for smokers who quit sooner after lung cancer diagnosis. I’ve copied the study summary below. Just to be clear, the research evidence shows that in the vast majority of cancer diagnoses, health outcomes will be improved by quitting smoking.


Impact of smoking cessation before resection of lung cancer: a Society of
Thoracic Surgeons General Thoracic Surgery Database study.
Mason DP, Subramanian S, Nowicki ER, Grab JD, Murthy SC, Rice TW, Blackstone EH. Ann Thorac Surg. 2009 Aug;88(2):362-70; discussion 370-1.

Department of Thoracic and Cardiovascular Surgery, Heart and Vascular Institute,
Cleveland Clinic, Cleveland, Ohio 44195, USA. masond2@ccf.org

BACKGROUND: Smoking cessation is presumed to be beneficial before resection of
lung cancer. The effect of smoking cessation on outcome was investigated.
METHODS: From January 1999 to July 2007, in-hospital outcomes for 7990 primary
resections for lung cancer in adults were reported to the Society of Thoracic
Surgeons General Thoracic Surgery Database. Risk of hospital death and
respiratory complications was assessed according to timing of smoking cessation,
adjusted for clinical confounders. RESULTS: Hospital mortality was 1.4% (n =
109), but 1.5% in patients who had smoked (105 of 6965) vs 0.39% in those who had
not (4 of 1025). Compared with the latter, risk-adjusted odds ratios were 3.5 (p
= 0.03), 4.6 (p = 0.03), 2.6 (p = 0.7), and 2.5 (p = 0.11) for those whose timing
of smoking cessation was categorized as current smoker, quit from 14 days to 1
month, 1 to 12 months, or more than 12 months preoperatively, respectively.
Prevalence of major pulmonary complications was 5.7% (456 of 7965) overall, but
6.2% in patients who had smoked (429 of 6941) vs 2.5%% in those who had not (27
of 1024). Compared with the latter, risk-adjusted odds ratios were 1.80 (p =
0.03), 1.62 (p = 0.14), 1.51 (p = 0.20), and 1.29 (p = 0.3) for those whose
timing of smoking cessation was categorized as above. CONCLUSIONS: Risks of
hospital death and pulmonary complications after lung cancer resection were
increased by smoking and mitigated slowly by preoperative cessation. No optimal
interval of smoking cessation was identifiable. Patients should be counseled to
stop smoking irrespective of surgical timing.

The CNN interview transcript is at:
http://transcripts.cnn.com/TRANSCRIPTS/0909/19/lkl.01.html

Labels: cancer, cessation, cigarette, CNN, diagnosis, George Fisher, jonathan foulds, Larry King, Patrick Swayze, Smoking, survival

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Smoking and HIV.

Twenty years ago, people who found out they had the Human Immunodeficiency Virus (HIV) felt as though they had been given a death sentence. At that time we did not have medicines that had been shown to be very effective in slowing the progression of the virus and preventing the onsite of diseases associated with AIDS. A large proportion of people who are HIV+ are also smokers, partly because some of the lifestyle behaviors that put one at risk of HIV also are risk factors for smoking (e.g. people who exhibit high risk behaviors such as having unprotected sex with multiple partners, or using intravenous drugs, also are much more likely to smoke). Unfortunately, back in the days before effective treatments for HIV/AIDS, HIV+ smokers didn’t see much point in quitting smoking because they perceived it as very likely that they would die from AIDS before suffering from smoking-caused diseases like lung cancer.

However, in the twentieth century we now know that with proper use of antiretroviral therapies, a 25 year-old who is HIV+ will likely live at least another 35 years, and probably longer with medical advances during that time. This is good news for people who are HIV+. Unfortunately one thing that hasn’t changed in line with effective HIV treatment is the perception of how important it is to quit smoking if you have HIV. While the smoking prevalence among U.S. adults recently dipped below 20%, studies among people who are HIV+ find a smoking prevalence of 45-74%. Often providers, recognizing that having HIV can lead to many stresses and challenges, feel reluctant to tackle the patient’s tobacco dependence. But there are many reasons why it is, if anything, MORE important to quit smoking if you are HIV+. Here are a few:

-Some of the antiretroviral medicines are metabolized more quickly if you smoke

-There is some evidence that antiretroviral medicines may increase cardiovascular risks, as does smoking, so it is important to avoid a double risk

- HIV+ smokers are three times more likely to contract certain serious AIDS-defining illnesses, such as bacterial pneumonia.

There has not been a very large amount of research on smoking cessation specifically in people with HIV, but the studies published so far tend to find results that are highly consistent with the studies in the general population of smokers. So there is every reason to expect that treatments proven effective for smoking cessation (e.g. nicotine replacement therapy and counseling) will also help HIV+ smokers to quit. Some specialist services are now being developed. One weblink was recently sent to me by AIDS specialist and colleague Dr Jonathan Shutter, and is worth checking out at: www.positivelysmokefree.com

I’d be interested in hearing comments on that website and also any experiences of quitting smoking after a positive HIV test.

Labels: AIDS, cessation, cigarette smoking, HIV, jonathan foulds, tobacco

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NRT to reduce and eventually quit smoking: does it work?

The package labeling recommendations and normal practice for use of nicotine replacement therapy (NRT, i.e. nicotine patch, gum etc) involves the smoker in picking a day when they will abruptly stop smoking, and start using the NRT as a substitute for smoking. However, over recent years product labeling in some countries (e.g. Great Britain) have allowed some of these products to be used to help the smoker initially reduce their tobacco consumption gradually before eventually quitting. This method has been called, “nicotine assisted reduction to stop”.

Earlier this year Dr David Moore and colleague at the University of Birmingham published a review of all randomized trials comparing NRT with other interventions in smokers declaring an interest in cutting down their cigarette consumption, but no intention to quit abruptly. The primary outcome examined in the review was 6 months of sustained abstinence from tobacco, and they compared the proportion achieving that using NRT with the proportion achieving that outcome when using a comparative intervention (placebo NRT). Note that all of the studies were conducted “double blind”, meaning that neither the smoker nor the researchers were who received NRT and who received placebo NRT until the end of the studies.

The study found 7 trials comparing NRT with placebo NRT. Most of the trials involved about 6 clinic visits. And allowed use of the NRT or placebo for around 12 months, with follow-up typically extending 3-12 more months. The participants in these studies were typically very heavy smokers, averaging over 25 cigarettes per day.

In the final analysis of all the trials, there were around a thousand smokers allocated to NRT and a similar number allocated to placebo NRT. 7% of those using NRT achieved 6 months sustained tobacco abstinence compared with 3 % of those using placebo NRT. All of the other outcomes were also better for the NRT group. For example, 22% of those using NRT had reduced their cigarette consumption by at least 50% at the end of the studies, as compared with 16% of those allocated to use placebo NRT.

There was little evidence to suggest that using NRT while continuing to smoke is dangerous (over and above the dangers of smoking). 4 people died who had used NRT, and 4 died who had used placebo. No other serious adverse events were more likely in the NRT condition. The only symptom found to be more common among those using NRT was nausea, with 9% experiencing nausea who had used NRT, compared to 5% who had used placebo. Very few people discontinued use of either active or placebo NRT because of adverse events ( <2% of each).

So what does this mean? On the one hand it is rather impressive that when you take a large group of smokers who say they are interested in reducing their consumption but are not interested in quitting, and give them NRT gum or inhaler to use for a long period of time, that in fact a significant (but small) proportion actually quit smoking (7%) and a larger proportion (22%) manage to sustain reduced smoking.

On the other hand, there were some characteristics of most of these research studies that make the situation quite different from the “real world” situation of smokers purchasing NRT for “reduce to quit” on their own. One difference is that in these studies the participants were provided with 6 visits including brief counseling to continue reducing their consumption. In the real world that is frequently unavailable (although it could be provided by networks of clinics, and telephone quitlines). In addition, because they were participating in placebo-controlled research studies, all of the participants were given their NRT for free. I understand the good reasons why the research has to be carried out this way, but I suspect it may have a relatively large influence on smoker behavior. I suspect that a much lower proportion of smokers would continue paying out of pocket for BOTH cigarettes and NRT for months and months, particularly if they had no intention of quitting (which implies that the double paying would continue forever).

So for me the message is that if you are a smoker who is not ready to quit abruptly and use NRT in the traditional way, then NRT can help you reduce your cigarette consumption gradually, and by doing this you are more likely to succeed in quitting in the long term. Importantly, the evidence suggests that dual use of cigarettes and nicotine gum or inhaler is not dangerous in terms of nicotine overdose.

Given that we know it is so easy to go back to regular smoking after a brief period of abstinence, I’d recommend that anyone thinking of following this gradual reduction program should have a clear plan and intention to quit smoking completely by a certain date, and that date should not be too far in the future (a month is OK, but 9 months is way too long for most people to persist with dual use towards quitting).

I’d also recommend that those using NRT this way really try to maximize their NRT use and minimize cigarette smoking as early as possible. That way they are more likely to learn to enjoy the NRT and get used to using it as their source for nicotine. Using minimal NRT only in places where you can’t smoke, is more likely to continue the use of cigarettes as the primary source for nicotine.

I’d be interested to hear comments from anyone who has used NRT, or any other methods, to gradually reduce their cigarette consumption. It would also be useful for readers to hear from the experiences of others. Have you tried gradual cigarette reduction, and how did it go?

The published paper by Dr Moore and colleagues can be accessed in full for free at:
http://www.bmj.com/cgi/content/full/338/apr02_3/b1024

Labels: cessation, cigarette smoking, David Moore, jonathan foulds, NRT, smoking reduction

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Avoid the vacation relapse

As we have discussed many times on this forum, quitting smoking can be difficult, but staying quit can be even harder. Part of the reason that relapse is so common among smokers who initially quit successfully (e.g. for a month) is that whereas during the first month the new ex-smoker is really determined and focused on quiting, its hard to maintain that level of motivation forever. The novelty wears off, and then a combination of circumstances leads to a lapse. The most common things leading to a lapse smoke are: availability of tobacco, experience of a negative mood state (e.g. anger, depression, anxiety, etc), and thoughts that enable smoking (“one wont hurt”….”it doesn’t really count if its someone else’s” etc).

Many ex-smokers say that they particularly want to smoke when they are in a “stressful” situation. At this time of year many of us are on or preparing to go on a vacation…often with family. Now although vacations are supposed to be fun and maybe relaxing, very often it doesn’t turn out that way. In fact vacation trips typically get a large number of points on “stress scales” that are designed to measure how much stress an individual has experienced recently. Part of the reason is that any change in ones life requires coping and adjustment and a vacation trip involves considerable changes (travel, different routine, different people etc). Family vacations in particular can be stressful to the parents (and also sometimes for the kids) and sometimes that stress can increase the risk of trying a cigarette again.

Even for people going on vacation without the kids, vacations can trigger lapse smoking. Very often vacations are viewed as a time to relax and wind down, or to blow off a bit of steam. That could include drinking alcohol and eating more than usual and also smoking. Some vacation lapses occur because the individual convinces him/herself that it doesn’t count if its on vacation. Unfortunately, as many of you know, these “innocent” lapse cigarettes very often lead to a full relapse.

So how can that be avoided? The first rule is “forewarned is forearmed”. This means that being aware that the although the vacation is intended to be fun, it may have its stressful moments which may trigger some desires to smoke. The next thing is to try to anticipate some of the triggers and make plans to avoid lapse smoking. Part of these plans should relate to how vulnerable you feel to relapsing. If you have only just quit a few weeks ago, and are still craving a cigarette on a frequent basis, then its probably not a great plan to go on vacation with a group of smokers to a place where smoking in bars and restaurants is allowed, (e.g. Las Vegas). Similarly, if you are still taking some form of smoking cessation medicine it is important to make plans in advance to ensure that you take enough with you so you don’t run out.

There are a few other things that you should prepare for. If you are flying internationally or even to certain US states you will probably have the opportunity to buy much cheaper cigarettes than in your home state. That should be anticipated and not treated as an opportunity too good to miss. It is also worth doing a bit of research to find out the indoor smoking policies at the place you are going. For those of us who are lucky enough to live in a place that has band smoking indoors it can come as a bit of a surprise to vacation in a place where half the people in the bar appear to be smoking. One final thing to do is to take stuff with you that you will find enjoyable and that can help you relax and take your mind off smoking. For some people it will be a couple of good books, for some its their Ipod with their favorite music (and don’t forget the charger), and for others it’s the running shoes so you can get fit while you have the time. Sometimes being on vacation and finding yourself at a loose end on a rainy afternoon can lead to thoughts of smoking also.

Of course the main thing is to go into the vacation with a positive attitude…and plan to do the fun and healthy things that it is sometimes hard to find time for when we are busy working or looking after the home. Make up your mind that nomatter what happens on the vacation, if you can return home without smoking that will be a success. Enjoy that hard earned vacation and the money you have saved by not smoking!

Labels: alcohol problem relapse, cessation, cigarette smoking, jonathan foulds, lapse

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Effects of nicotine replacement for smoking reduction

This week, Dr David Moore and colleagues at the University of Birmingham (UK) published a review of randomized controlled trials of nicotine replacement for reducing smoking in smokers who initially did not plan to quit. The review, published in the BMJ, included 7 trials involving 2767 smokers.

They found that of smokers entering these trials intending only to reduce their smoking almost 7% of those who used nicotine replacement and just over 3% of those who used placebo NRT eventually quit smoking for 6 months.

The study also examined whether there were any signs that it is unsafe to use nicotine replacement therapy while still smoking. They found that discontinuation of treatment due to serious adverse events was rare (less than 2% for both NRT and placebo groups). The only symptom that appeared to be significantly more frequent in those receiving NRT (rather than placebo) was nausea. 9% of those using NRT experienced some nausea and 5% of those receiving placebo reported nausea. So there does not appear to be any serious safety concerns with using NRT while reducing smoking.

The authors concluded that nicotine replacement therapy is an effective intervention in achieving sustained smoking abstinence for smokers who have no intention or are unable to attempt an abrupt quit. Most of the evidence, however, comes from trials with regular behavioral support and monitoring and it is unclear whether using nicotine replacement therapy without regular contact would be as effective.

In one sense it is impressive that NRT is able to produce significantly more long term quitters, given that none of the people recruited to these trials wanted to quit at that point. On the other hand, the quit rate is not very high (under 7%).

For me, the other practical problem that wasn’t really addressed in the main conclusions was the issue of cost/payment for NRT. In these research trials participants are typically provided with NRT for free. But I don’t see many smokers, who are not trying to quit, paying out of pocket for NRT for 6-18 months while still paying for their cigarettes. Similarly, why publicly funded healthcare systems may subsidize NRT and counseling for those trying to quit, I don’t see this happening for smokers simply trying to gradually reduce with no intention of quitting.

So while it is good to know that NRT is safe and effective as an aid to reduced smoking, and that when used that way more smokers actually quit, I don’t see NRT being widely used in the real world the way it was in these clinical trials.

It is interesting that exposing smokers who arn’t planning to quit to NRT results in more of them quitting. I suspect that the same thing would happen were NRTs promoted as a treatment for nicotine withdrawal symptoms during periods of brief/temporary abstinence (eg while at work, in smokefree environments etc). Some are concerned that such use would diminish quitting. I suspect it would just teach many smokers that they can function quite well by getting their nicotine from a less harmful source…and prompt more to switch to NRT completely.

You can read the full report at: http://www.bmj.com/cgi/content/abstract/338/apr02_3/b1024

Labels: cessation, cigarette smoking, harm reduction, jonathan foulds, NRT

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Rethinking drinking

For very many smokers, drinking and smoking go together hand in hand. Consequently, when smokers try to quit smoking they often find that having a drink of alcohol triggers the desire to also have a smoke. In addition, once alcohol starts to cloud our thinking, ex-smokers sometimes “forget” that they are trying to quit smoking. So you are in a better position to quit smoking if you are already in control of your drinking, and able to avoid it completely if you wanted to during the first month of an attempt to quit smoking.

A new website has just been launched to help people check their drinking pattern, identify potential problems, and take steps to make sure their drinking is under control. http://www.rethinkingdrinking.niaaa.nih.gov was developed by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) to provide the best evidence-based advice to people who may have a drinking problem. It is very user-friendly and includes links to other resources. I’d recommend it to anyone who wonders if they may be drinking too much. It could also help you ensure your drinking is under control prior to a quit attempt.

For additional information on alcohol use while trying to quit smoking, check out:

Effects of alcohol on smoking cessation – 1. 5/29/07 http://www.healthline.com/blogs/smoking_cessation/2007/05/effects-of-alcohol-on-smoking-cessation.html

Effects of alcohol on smoking cessation – 2. 5/29/07 http://www.healthline.com/blogs/smoking_cessation/2007/05/effects-of-alcohol-on-smoking-cessation_29.html

Labels: alcohol problem relapse, cessation, cigarette smoking, jonathan foulds, NIAAA, rethinking drinking

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Should health care services provide treatment for addicted smokers?

Last week’s issue of the leading medical journal, “The Lancet” included two comment articles on the issue of whether it makes sense to fund healthcare services to help smokers to quit.

Professor Simon Chapman (University of Sydney) argued that cessation services devour resources that could be better used for anti-tobacco mass-media campaigns and that these services give people the impression that smokers are unlikely to succeed alone. He has argued before that smoking cessation clinics should be abandoned.

Professor John Britton (University of Nottingham) defended the role of smoking cessation services. He acknowledged that population-level interventions (e.g. laws banning smoking in public places) have a greater potential to impact population smoking prevalence, but argued that impacting population smoking prevalence is not their primary purpose (any more than chemotherapy for cancer aims to decrease the population prevalence of cancer). He pointed out that we need treatment for the most addicted smokers, that the evidence from England shows that very high numbers of smokers are willing to use services when available (680,000 in England last year), and that cessation services are one of the most cost-effective healthcare interventions available.

I think part of the problem here is the perception that within the tobacco control tools at our disposal “population impact” strategies and “individual treatment” strategies represent an either/or choice. Quite simply, they are not. There are plenty of places where activities to increase the price of tobacco, ban smoking in public places, etc occur simultaneously with activities to provide more smokers with treatment to help them quit smoking (e.g. the United Kingdom, or some U.S. states). The relevant population-impact policy here is to persuade healthcare systems to routinely provide brief and specialist tobacco treatment options.

It is usually the case that population level interventions have a larger population impact than individual clinical interventions. Whether that involves eradicating the breeding-grounds of malaria-carrying mosquitos near population centers, or building a water purification plant it does not follow that it’s a waste of time to use anti-malarial medicines or treat people who catch infections.

Comparing effective population-based public health interventions with effective clinical interventions is like comparing apples and broccoli. They are both good for you, and having both is better than just one or neither. If the argument is about the use of scarce resources then tobacco treatment services should be evaluated against other clinical services (e.g. the treatment of alcohol problems, hypertension, diabetes or breast cancer), rather population-based policy interventions. If Chapman believes tobacco treatment services should be abandoned on the grounds of cost-effectiveness (on measures such as cost per quality adjusted life year gained), then he should simultaneously be arguing that a vast number of clinical services should be abandoned first, as tobacco treatment has amongst the biggest bang for the clinical treatment buck.

I have the utmost respect for both John Britton and Simon Chapman as tobacco control experts. But in this debate I have to agree with Professor Britton. If one wants to reduce the harms to health caused by smoking, it makes more sense to argue for more population-based interventions AND more clinical interventions, so that those addicted smokers who are persuaded to try to quit can have a better chance of doing so successfully.

Some recent statistics from the English smoking cessation services can be found at:
http://www.ic.nhs.uk/webfiles/publications/Stop%20smoking%20ANNUAL%20bulletins/SSS0708/SSS%202007-08%20final%20format%20v2.pdf

For the rationale for comprehensive tobacco control:
http://www.healthline.com/blogs/smoking_cessation/2008/05/why-comprehensive-tobacco-control.html

For a description of what a specialist tobacco treatment clinic does:
http://www.healthline.com/blogs/smoking_cessation/2008/02/what-does-tobacco-treatment-clinic-do.html

Labels: cessation, cigarette smoking, John Britton, jonathan foulds, nicotine dependence treatment, public health, services, simon chapman

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47 posts in 2008

This link contains a list of my posts in 2007:
http://www.healthline.com/blogs/smoking_cessation/2007/12/ninety-five-posts-in-2007.html

and here are the ones from 2008….

Time to quit….now. 1/1/08
http://www.healthline.com/blogs/smoking_cessation/2008/01/time-to-quitnow.html

Not a puff. 1/6/08
http://www.healthline.com/blogs/smoking_cessation/2008/01/not-puff.html

How does your state or country tackle tobacco? 1/12/08
http://www.healthline.com/blogs/smoking_cessation/2008/01/how-does-your-state-or-country-tackle.html

100. Do you wake at night to smoke? 1/16/08
http://www.healthline.com/blogs/smoking_cessation/2008/01/do-you-wake-at-night-to-smoke.html

101.Swedish Snus: A Reply to Professor Tomar. 1/22/08
http://www.healthline.com/blogs/smoking_cessation/2008/01/swedish-snus-reply-to-professor-tomar.html

102.What does a tobacco treatment clinic do? 2/6/08
http://www.healthline.com/blogs/smoking_cessation/2008/02/what-does-tobacco-treatment-clinic-do.html

103.New study compares Chantix to the nicotine patch. 2/11/08
http://www.healthline.com/blogs/smoking_cessation/2008/02/new-study-compares-chantix-to-nicotine.html

104.What is in cigarette smoke? 2/17/08
http://www.healthline.com/blogs/smoking_cessation/2008/02/what-is-in-cigarette-smoke.html

105.Snus use in Sweden: another reply to Tomar. 2/19/08
http://www.healthline.com/blogs/smoking_cessation/2008/02/snus-use-in-sweden-another-reply-to.html

106.Chantix and depression on stopping smoking. 2/26/08
http://www.healthline.com/blogs/smoking_cessation/2008/02/chantix-and-depression-on-stopping.html

107. Marlboro Snus Isn’t Really Snus 3/4/2008
http://www.healthline.com/blogs/smoking_cessation/2008/03/marlboro-snus-isnt-really-snus.html

108. Smoking and lung function 3/7/08
http://www.healthline.com/blogs/smoking_cessation/2008/03/smoking-and-lung-function.html

109. Wearing the patch prior to quitting 3/21/2008
http://www.healthline.com/blogs/smoking_cessation/2008/03/wearing-patch-prior-to-quitting.html

110. Why Chantix may reduce alcohol consumption. 3/22/2008
http://www.healthline.com/blogs/smoking_cessation/2008/03/why-chantix-may-reduce-alcohol.html

111. How have New York and New Jersey reduced smoking? 3/24/2008
http://www.healthline.com/blogs/smoking_cessation/2008/03/how-have-new-york-and-new-jersey.html

112. Buy cigarettes on the internet? Expect a large invoice. 3/26/2008
http://www.healthline.com/blogs/smoking_cessation/2008/03/buy-cigarettes-on-internet-expect-large.html

113. Lung Cancer, Spiral CT and Tobacco Industry Funding 3/26/2008
http://www.healthline.com/blogs/smoking_cessation/2008/03/lung-cancer-spiral-ct-and-tobacco.html

114. Smoking and Lung Cancer 3/29/2008
http://www.healthline.com/blogs/smoking_cessation/2008/03/smoking-and-lung-cancer.html

115. Can cigarettes be made less deadly? 4/20/2008
http://www.healthline.com/blogs/smoking_cessation/2008/04/can-cigarettes-be-made-less-deadly.html

116. Vote for Healthline for Webby Award 4/20/2008
http://www.healthline.com/blogs/smoking_cessation/2008/04/vote-for-healthline-for-webby-award.html

117. Which U.S. states smoke most and least? 4/21/2008
http://www.healthline.com/blogs/smoking_cessation/2008/04/which-us-states-smoke-most-and-least.html

118. Smoking and suicide. 4/22/08
http://www.healthline.com/blogs/smoking_cessation/2008/04/smoking-and-suicide.html

119. Tobacco harm reduction. 4/25/08
http://www.healthline.com/blogs/smoking_cessation/2008/04/tobacco-harm-reduction.html

120. Become an ex. 4/30/08
http://www.healthline.com/blogs/smoking_cessation/2008/04/become-ex.html

121. Which kids in the US are most likely to use tobacco? 5/6/08
http://www.healthline.com/blogs/smoking_cessation/2008/05/which-kids-in-us-are-most-likely-to-use.html

122. Unwise to cut tobacco control funding in tough times. 5/9/08
http://www.healthline.com/blogs/smoking_cessation/2008/05/unwise-to-cut-tobacco-control-funding.html

123. Thanks to grand rounds 4.34 at Health Business Blog. 5/17/08
http://www.healthline.com/blogs/smoking_cessation/2008/05/thanks-to-grand-rounds-434-at-health.html

124. Why comprehensive tobacco control? 5/18/08
http://www.healthline.com/blogs/smoking_cessation/2008/05/why-comprehensive-tobacco-control.html


125. Thanks to the Dinosaur for grand rounds. 5/28/08
http://www.healthline.com/blogs/smoking_cessation/2008/05/thanks-to-dinosaur-for-grand-rounds.html

126. Chantix (varenicline) safety. 5/28/08
http://www.healthline.com/blogs/smoking_cessation/2008/05/chantix-varenicline-safety.html

127. Chantix safety at the US Veterans Affairs health service. 5/31/08
http://www.healthline.com/blogs/smoking_cessation/2008/05/chantix-safety-at-us-veterans-affairs.html

128. Are Americans switching to smokeless tobacco? 6/09/08
http://www.healthline.com/blogs/smoking_cessation/2008/06/are-americans-switching-to-smokeless.html

129. Doctors under the influence: the real story. 6/30/2008
http://www.healthline.com/blogs/smoking_cessation/2008/06/doctors-under-influence-real-story.html

130. Happy Independence Day. 7/5/08
http://www.healthline.com/blogs/smoking_cessation/2008/07/happy-independence-day.html

131. Extended treatment for some addicted smokers. 7/06/08
http://www.healthline.com/blogs/smoking_cessation/2008/07/extended-treatment-for-some-addicted.html

132. What proportion of smokers become addicted? 7/13/08
http://www.healthline.com/blogs/smoking_cessation/2008/07/what-proportion-of-smokers-become.html

133. Parental use and restrictions influence teen smoking. 7/19/08
http://www.healthline.com/blogs/smoking_cessation/2008/07/parental-tobacco-use-and-restrictions.html

134. MPOWER: Bloomberg and gates pledge millions to tobacco control. 7/27/08
http://www.healthline.com/blogs/smoking_cessation/2008/07/mpower-bloomberg-and-gates-pledge.html

135. Congress votes for FDA tobacco regulation. 7/30/08
http://www.healthline.com/blogs/smoking_cessation/2008/07/congress-votes-for-fda-tobacco.html



136. UK National Smoking Cessation Conference. 8/1/08
http://www.healthline.com/blogs/smoking_cessation/2008/08/uk-national-smoking-cessation.html

137. Carbon-monoxide in cigarette smoke. 8/0208
http://www.healthline.com/blogs/smoking_cessation/2008/08/carbon-monoxide-in-cigarette-smoke.html

138. Effect of extended counseling on smoking cessation. 8/10/08
http://www.healthline.com/blogs/smoking_cessation/2008/08/effect-of-extended-counseling-on.html

139. Cigarette health warnings and bogus buy-ology. 12/16/08
http://www.healthline.com/blogs/smoking_cessation/2008/12/cigarette-health-warnings-and-bogus-buy.html

140. Facts and fiction on stopping smoking. 12/20/08
http://www.healthline.com/blogs/smoking_cessation/2008/12/facts-and-fiction-on-stopping-smoking.html

141. How to stop smoking with varenicline (Chantix). 12/20/08
http://www.healthline.com/blogs/smoking_cessation/2008/12/how-to-quit-smoking-with-varenicline.html

142. Happy holidays. 12/25/08
http://www.healthline.com/blogs/smoking_cessation/2008/12/happy-holidays.html

143. Get ready for smoke-free 2009. 12/28/08
http://www.healthline.com/blogs/smoking_cessation/2008/12/get-ready-for-smoke-free-2009.html

Labels: blog, cessation, cigarette smoking, freedom from smoking, healthline, jonathan foulds, nicotine

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Why are mentholated cigarettes more addictive?

My colleagues and I just published a research study which examined the quit rates of patients attending our specialist Tobacco Dependence Clinic, and focused on the differences between those who smoked mentholated cigarettes and those who smoked non-menthol cigarettes.
Consistent with numerous other studies, we found that far more African American (81%) and Latino (66%) smokers smoked menthols, as compared with non-Latino Whites (32%). But the more interesting finding was that while African American and Latino smokers of non-menthol cigarettes had similar quit rates to whites, the quit rates of those smoking menthols was significantly lower. For example, African Americans who smoked menthols had half the odds of quitting of African Americans who smoked regular non-menthol cigarettes.
This “menthol effect” on quitting occurred despite the fact that menthol smokers typically smoked fewer cigarettes per day. So why do many smokers, and particularly African Americans and Latinos find menthol cigarettes to be particularly hard to quit?
In an earlier study we found that menthol cigarette smokers have higher nicotine, cotinine and carbon-monoxide levels than non-menthol smokers. This suggests that they tend to inhale more smoke from each cigarette. Menthol stimulates cold receptors and may therefore cool the harshness of cigarette smoke and make it easier to inhale larger amounts. It seems that the “menthol effect” is more pronounced in situations where the smoker may need to try to inhale more nicotine from fewer cigarettes. Thus in New Jersey, where we have amongst the highest cigarette taxes in the country, many people on low incomes can no longer afford to smoke a pack or two per day, but they have become addicted to that amount of nicotine. When a smoker reduces their cigarette consumption it is typical that they “compensate” by inhaling more from each one. This can be easily achieved, without any conscious effort, by taking larger puffs. But there comes a point where the larger puffs are difficult to sustain because of the smoke harshness causing an unpleasant effect on the throat. But for menthol cigarettes the larger puff means a larger cooling effect from the menthol. So the menthol enables the smoker to inhale more nicotine per cigarette, and perhaps obtain a stronger “hit” and become more addicted.
So it is possible that even if you are a relatively light smoker of menthol cigarettes, you may be more nicotine dependent than the simple daily cigarette consumption would imply. A summary of the new study may be found at: http://www.ncbi.nlm.nih.gov/pubmed/19222622?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum


For more information about our Tobacco Dependence Clinic, check out: http://www.healthline.com/blogs/smoking_cessation/2008/02/what-does-tobacco-treatment-clinic-do.html

Labels: addiction, cessation, cigarette smoking, jonathan foulds, menthol

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What percentage of smokers can quit for $750?

It is sometimes suggested that the best way to get people to quit smoking is to pay them a decent amount of money to do so. Studies to date have found that financial incentives don’t have much effect on quitting, but in these studies the incentives on offer were often relatively weak (eg. $40).

However, a large trial has just been published in the New England Journal of Medicine today, which examined this issue. The team of researchers, led by Dr Kevin Volpp of the Philadelphia VA Medical Center, recruited 878 smokers at a large multinational company and randomly allocated each one to either (a) information about smoking cessation programs available within 20 miles or (b) the same information, plus a $100 incentive for completing a program, $250 incentive for quitting during the first 6 months, and $400 incentive to remain quit 6 months later (i.e. total potential incentive = $750).

What proportion of smokers do you think would be quit 9-12 months after receiving the incentive offer?

In this study 5% of the no-incentive group attended the smoking cessation programs, but 15% of the incentive group did. 21% of the incentive group quit in the first 6 months, compared with 12% of those with no incentives. And 15% of the incentive group remained quit 9-12 months after receiving the offer, compared with 5% of those just receiving the information about quit smoking programs (but no incentives).

Among the very heavy smokers (2 packs/day or more) in the study none of those with no incentives succeeded in quitting (0/27), and 2/22 (9%) of those offered the incentives succeeded in quitting.

Among those who participated in smoking cessation programs those who had incentives had higher quit rates (46% vs 21%).

This study therefore shows that if smokers are offered access to smoking cessation programs and a $750 incentive to quit, they are more likely to succeed (15%), than those with no incentive (5%).

The study participants were all employees and 90% were white. It remains to be seen if this effect would generalize to other groups. The authors point out the estimated financial benefit of having employees stop smoking is $3400 per year (savings in healthcare costs, absenteeism etc), and that it may therefore be cost effective to provide employees with incentives to quit. The effectiveness of such incentives also requires that smoking cessation programs be available, which they often are not.

It is worth highlighting what this study did NOT show. It did not show that all you have to do to get smokers to quit is offer them $750. In fact 85% of the smokers offered that incentive were unable to quit. Secondly, the findings from this study do not imply that we don’t need treatment services for smokers, we just need to pay them to quit. On the contrary, all the smokers in this study had treatment services available to them.

So it looks like an extra 10% of smokers can quit when offered $750 incentive, and when some treatment services are available. This is a worthwhile increase. The more complicated challenge is turning that finding from a research study into something that could be implemented on a wider scale. I dont believe there will be general acceptance of the principle of paying people to change their unhealthy behaviors. I also suspect that there may be more problems of implementation outside a thorough research study. Whats to stop a non-smoker claiming to be a smoker so they will be eligible for the bonus when they are (still) not smoking a year later? Can the average employer arrange the biochemical verifications necessary for the research study?

Ultimately I believe money may be better spent making sure all smokers have easy access to quality treatment services at no cost, and making sure they are fully aware of the personal benefits that will come to them from succeeding in quitting (cost savings from not buying cigarettes, improved health, lower health insurance premium etc).

Ref: Volpp K et al. A randomized, controlled trial of financial incentives for smoking cessation. N Eng J Med, 2009, 360:699-709

Labels: cessation, cigarette smoking, financial incentive, jonathan foulds

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Get ready for a smoke-free 2009

So here we are approaching the end of 2008 and the beginning of 2009. Wouldn’t it be great to reach this time next year having gone the whole year without smoking? So now is the time to really get yourself ready to quit. One of the first things to do is to choose a Quit Date.

Many people at this time of year will choose January 1, and that is as good a time as any. Some may choose to put it off a little for good reasons. One reason might be “I’m going to be drinking and smoking on New Year’s eve and I want to start my quit day with a clear head and without having smoked at all after midnight the night before.” In that case why not pick January 2 as your quit day?

Another reason to delay a little bit might be because you intend to use Chantix or Zyban and havn’t got your prescription yet, and so won’t have time to get it and take it for 7 days (as advised on the labeling) prior to the quit day by January 1. In that case see your doctor and get started on your medicine as soon as possible.But regardless of which individual day you choose to quit on, don’t delay it for too long. I’d suggest that any date that is more than two weeks into the year is delaying too long unless you have an exceptionally good reason. And once you have chosen your date, its immediately time to start getting ready.You may want to review my post on the health effects of smoking to remind yourself of some of the main reasons for quitting:How bad is smoking for your health? 2/18/07 http://www.healthline.com/blogs/smoking_cessation/2007/02/how-bad-is-smoking-for-health.html

You may want to plan how you might cope with nicotine withdrawal symptoms, as suggested in this post: Ten tips for coping with nicotine withdrawal. 3/7/07 http://www.healthline.com/blogs/smoking_cessation/2007/03/ten-tips-on-coping-with-tobacco.html

You will certainly want to make a plan to get rid of all your tobacco:
Get rid of all your tobacco. 6/16/07 http://www.healthline.com/blogs/smoking_cessation/2007/06/get-rid-of-all-your-tobacco.html
…and you should consider whether you are going to use a pharmacological aid to smoking cessation, like nicotine replacement therapy:Which nicotine replacement therapy? 6/19/07 http://www.healthline.com/blogs/smoking_cessation/2007/06/which-nicotine-replacement-therapy.html

It may also be worthwhile checking out some of the best websites for helping people quit smoking. These are discussed at: “Become an Ex”: (April 30, 2008)
http://www.healthline.com/blogs/smoking_cessation/2008/04/become-ex.html

It is also a good idea to be thinking about what has tripped you up on any prior quit attempts, and what you can do differently this time in order to succeed. In particular, its worth anticipating specific things coming up in your life in the next week or two that may be a risk for relapse. Make a plan of how you will manage these situations without smoking.

I’d be interested to hear from anyone out there who is currently planning to quit smoking at New Year. Use the “comment” option on the blog to tell us how you are planning to quit, and let us know of your progress.

Labels: 2009, cessation, cigarette smoking, jonathan foulds, preparation

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UK National Smoking Cessation Conference

Probably the best conference on smoking cessation over recent years has been the UK National Smoking Cessation Conference. The UK is probably the only country to have a national and fairly comprehensive smoking cessation service involving widespread access to trained smoking cessation counselors, access to low cost smoking cessation medicines (via the UKs National Health Service), as well as telephone and internet help. As a result, this conference is the largest gathering of smoking cessation counselors in the world, and also attracts many attendees and speakers from other countries.

It consistently has very lively speakers and many of the presentations are available online with the full slides and audio recording. The 2008 conference just became available online and includes many interesting presentations. For example, an interesting slide show by Rachna Kasliwal describing results of a study of adverse events in patients using Chantix is available at: http://www.uknscc.org/2008_UKNSCC/speakers/rachna_kasliwal.html

An interesting debate on the topic;
“Debate: This house believes that hypnotherapy and acupuncture should be treatments provided by NHS Smoking Services” is also available with full audio and slides at:
http://www.uknscc.org/2008_UKNSCC/speakers/debate.html

I also thought the presentation by Dr Paul Eveyard on “Does stopping smoking mean putting on weight?” was very interesting. The audio recording and his slides are available at:
http://www.uknscc.org/2008_UKNSCC/speakers/paul_aveyard.html

The full archive of each conference from 2005-2008 is now available online at:
http://www.uknscc.org/index.html

It provides an excellent source of information from leading experts on all aspects of stopping smoking.

Labels: cessation, cigarette smoking, conference, jonathan foulds, UK

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Extended treatment for some addicted smokers

The brand new US Public Health Service Guideline on the Treatment of Tobacco Use and Dependence was written after an extremely thorough review of all the randomized controlled smoking cessation trials in the literature with at least 6 months follow-up.

http://www.surgeongeneral.gov/tobacco/

The guideline was also written by a large group of experts on tobacco treatment and healthcare. That guideline stated:

“For some patients it may be appropriate to continue medication treatment for periods longer than is usually recommended. Although weaning should be encouraged for all patients using medications, continued use of such medications is clearly preferable to a return to smoking with respect to health consequences.” (p126).

So what is meant by extended or “long term” treatment for tobacco dependence?

Most pharmacological tobacco dependence treatments (e.g. bupropion/Zyban, nicotine patch, nicotine gum) last for 7-12 weeks. Most non-pharmacological treatment is even shorter, e.g. the number of counseling sessions reimbursed by Medicare is 4 (>10 minutes) and group treatment most commonly consists of 6 weekly sessions. So in the field of tobacco dependence treatment, any treatment lasting longer than 12 weeks is considered “long term”. So is there any evidence that treatment lasting longer than 12 weeks may be safe and effective?

Williams et al (1) randomized patients to 52 weeks of varenicline (Chantix) or placebo. They found that varenicline was safe for a year of treatment and produced significantly higher quit rates at one year than placebo.

Tonstad and colleagues (2) treated 1927 smokers with the typical 12 weeks of varenicline and the 1236 who were not smoking at 12 weeks were then randomized to a further 12 weeks of varenicline or placebo (double blind). The question was, “does longer term treatment with varenicline prevent relapse over the next 12 weeks? By week 24, 30% of those who had varenicline had smoked, compared with 50% of those who had placebo for the last 12 weeks. So longer term varenicline resulted in more people succeeding in quitting smoking. When the participants were followed up at 12 months (i.e. at least 6 months off-drug for everyone) there were still more non-smokers among those who had varenicline for 24 weeks as compared to those who had it for 12 weeks.

But the added effects of longer duration treatment do not just apply to varenicline, or even just pharmacotherapy. Hall and colleagues (2004) (3) randomized smokers to standard 12 weeks of counseling and 8 weeks of nicotine patches plus either another 9 months of counseling, or 12 months of nortriptyline (an antidepressant that helps people quit smoking) or 12 months of placebo. At the one year follow-up, those who had nortriptyline and counseling for a year had a quit rate of 50%, as compared with only 18% for those who had nortiptyline but only 12 weeks of counseling, 30% for those who had 12 weeks of counseling and placebo, and 42% for those who had a year of counseling and placebo. The authors concluded that, “Comprehensive extended treatments that combine drug and psychological interventions can produce consistent abstinence rates that are substantially higher than those in the literature.” But as can be seen from the numbers, it was primarily the extended counseling that contributed to the unusually high one-year quit rates.

This study by Hall and colleagues was one of the first to really adopt the “chronic disease” model for smoking cessation, and it is also the one study to achieve the highest one year quit rates (50%).

The reality is that most smokers are not seeking extended (i.e. over 12 weeks) counseling or extended pharmacotherapy as a way to stop smoking. And many will not need it. The point is that those patients who have made a choice that they are willing to do whatever is necessary to save their life and become healthier by stopping smoking, and who appear likely to benefit from it, should be provided with extended treatment that appears likely to increase their chances. When 12 weeks of treatment have not succeeded in controlling hypertension, diabetes or asthma, we don’t expect our doctors to say, “oh well, never mind, it didn’t work and I won’t try to help you any more.” The same should go for tobacco dependence treatment. And when a patient has had 12 weeks of treatment but still feels vulnerable to relapse then there is evidence to suggest that the extended treatment may help them to remain smoke-free. The evidence is certainly not clear enough to recommend this to all patients, but it is sufficient to support it as an option for some.

(1) Williams KE, Reeves KR, Billing CB Jr, Pennington AM, Gong J. A double-blind study evaluating the long-term safety of varenicline for smoking cessation. Curr Med Res Opin. 2007 Apr;23(4):793-801.

(2) Tonstad S, Tønnesen P, Hajek P, Williams KE, Billing CB, Reeves KR;Varenicline Phase 3 Study Group. Effect of maintenance therapy with varenicline on smoking cessation: a randomizedcontrolled trial. JAMA. 2006 Jul 5;296(1):64-71.

(3) Hall SM, Humfleet GL, Reus VI, Muñoz RF, Cullen J. Extended nortriptyline and psychological treatment for cigarette smoking. Am J Psychiatry. 2004 Nov;161(11):2100-7.

Note: Jonathan Foulds has done paid work for pharmaceutical companies (Novartis, GSK, Celtic Pharma and Pfizer). This has included advising on potential new medicines, training health professionals, advising on clinical trial design, discussing barriers to quitting and reviewing applications for research grants. His main funding sources are mentioned in a funding statement on the bio page.

Labels: cessation, cigarette smoking, dependence, extended, jonathan foulds

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Are Americans Switching to Smokeless Tobacco?

A recent paper by Professor Brad Rodu of University of Louisville, School of Medicine and Dr Carl Phillips if the University of Alberta suggested that switching to smokeless tobacco is a viable smoking cessation option for American smokers.

The paper, published in the online Harm Reduction Journal, used data from the year 2000 National Health Interview Survey (NHIS) which asked 3622 male smokers and 3653 male former smokers about the methods used and outcome of their most recent attempt to quit smoking. Because the NHIS survey is administered to a fairly representative sample of the US population, Rodu and Phillips then used the results of the survey to estimate the total number of male smokers in the US using each quit rate and quitting smoking in the United States. So far this all sounds fairly sensible. However, the authors then took that fairly simple data and made rather far-reaching claims without critically examining the quality (and quantity) of data.

For example, the main conclusions drawn in the paper and its abstract (summary) were that a reasonably large number of smokers in the US (261,000) have quit smoking by switching to smokeless tobacco on their latest quit attempt. It is also claimed that the quit rate among those trying to quit smoking by switching to smokeless tobacco is higher than among those trying other methods (e.g. nicotine replacement therapy). However, examination of the data tables in the paper revealed that a total of only 33 people in the survey claimed to have quit smoking by switching to smokeless tobacco. Unfortunately this is too small a number to provide reliable estimates of numbers using this as a quit method nationally. The ubsurdity of using such very small samples to estimate national numbers is even clearer when one looks at the figures for those using the nicotine nasal spray (NNS). Only 3 people in the survey claimed to have used the nicotine nasal spray on their last quit smoking attempt, and none remained free of smoking at the time of the survey. Despite this extremely small sample, the authors went ahead and used it to estimate that at a national level,14,000 smokers used the NNS on their latest quit attempt and none (0%) succeeded.

One other issue with this study stems from the fact that the various smoking cessation aids differed in the time periods in which they were available. For example, while smokeless tobacco has been available for over 100 years, the pharmacological aids only became available in the 1980s and 1990s. So 48% of those who quit by using smokeless tobacco quit at least 10 years ago, compared to 11% of those who quit with the patch. In some ways this may make those quits on smokeless more impressive in that they are longer term quits, but it also serves to underline that in some ways these comparative figures are not comparing like with like. Smokers who quit 20-20 years ago may differ from those trying to quit in recent years, and memory for more distant events maybe less accuarate.

But overall, the biggest weakness of this study was the very small sample of participants who used smokeless tobacco in their quit attempt and then the inappropriate use of these very small numbers to estimate national numbers. Perhaps the main thing that can be concluded from this study report is that the vast majority of smoking cessation attempts in the United States do not involve the use of a proven smoking cessation aid, and a small but measurable proportion of smokers succeed in quitting smoking by switching to smokeless tobacco. If the NHIS survey uses similar questions in future it may be interesting to see how the pattern of use of smoking cessation aids changes over time.

I’d encourage smokers to use smoking cessation treatments that have been demonstrated to be safe and to increase your chances of success. These include counseling from a trained healthcare provider, nicotine replacement therapy, bupropion and varenicline.

The paper by Rodu and Philips is available at:
http://www.harmreductionjournal.com/content/5/1/18

Labels: cessation, cigarette smoking, comprehensice tobacco control, jonathan foulds, nicotine regulation reduction smoking smokeless

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Chantix (varenicline) Safety

Last week a report was released by an organization called the “Institute for Safe Medication Practices” (ISMP) which claimed to have safety concerns about Chantix (varenicline, also marketed as Champix outside the United States). The Executive Summary of the report made two main recommendations:

1. Chantix should be avoided or used with caution by persons operating aircraft, motor vehicles or other machines (e.g. power stations) where a lapse in alertness or motor control could have serious consequences.
2. Patients and doctors should excercise caution in the use of Chantix (generally) and “consider the use of alternative approaches to smoking cessation.”

Given that most of us drive a vehicle, the report is basically suggesting that varenicline is such an unsafe drug that it should be avoided. These are strong recommendations, and have immediately resulted in the Federal Aviation Authority (FAA) and Federal Motor Carrier Safety Administration (FMCSA) adding varenicline to their list of drugs that should not be used by pilots or truck drivers. The report itself has not been published in a peer-reviewed journal and so it is reasonable to assess the quality of the data on which it was based, and to evaluate whether the recommendations are warranted on the basis of that data.

The ISMP report was based on an analysis of the frequency and type of serious adverse events that have been reported to the US Food and Drug Administration (FDA) about Chantix, in comparison to other drugs. In particular, the report noted that by the 4th quarter of 2007 Chantix “accounted for more reports of serious adverse events in the United States than any other drug.” This amounted to 988 reports about Chantix in the 4th quarter, as compared with 372 (Oxycodone) to 640 (Interferon Beta) reports about the next 5 most reported drugs.

The report then selected a sample (3063) of the total reports (excluding foreign or unclear reports) for slightly more detailed analysis. It noted that a much larger proportion of the reports about Chantix came from consumers (57%) than is typical of other drugs (26%) for which health professionals are the predominant source. The report also noted that a lower proportion of the reports about Chantix (2.5%) reported deaths, as compared with 17% of reports about other drugs.

The report summarized the most frequent medical terms included in the reports about Chantix. By far the most common term used was nausea (593), which was more than twice as common as any other reported symptom. It was also noteable that among the most commonly reported medical symptoms mentioned in the adverse event reports, many are also recognized nicotine withdrawal symptoms (i.e symptoms known to increase when smokers quit smoking, particularly without any treatment medication), such as depression (287), insomnia (242), anxiety (217), and weight increase (141).

Problems with the ISMP report and its conclusions

There are a number of fundamental problems with the quality of the data, analysis and interpretation in the ISMP report. Before discussing some of these, it is worth discussing the way that reports of serious adverse events are delivered to the FDA. There are 4 main sources of reports.

1. Members of the public can send reports directly to FDA, either by mail or via an on-line reporting system (and I have provided the link on previous posts on this blog about Chantix to ensure that reports reach FDA).
2. Health professionals can report adverse events to FDA.
3. Lawyers sometimes report adverse events to FDA.
4. The manufacturer is required to report to FDA any reports that are brought to its attention directly. Those adverse events that are already mentioned on the product labeling are reported on a quarterly basis, and novel symptoms must be reported within 15 days (expedited).

Reports from the first 3 of these sources are entirely voluntary and are made in a rather haphazard way. The ISMP report estimated that typically between 1 and 10% of serious adverse events are actually reported to FDA. It is commonly found that AE reports peak around two years after the launch of a drug, even if the drug becomes used more often thereafter. The purpose of the FDA’s reporting and monitoring system is to facilitate post-marketing surveillance and enable detection of patterns of adverse events that could potentially be caused by a medicine but were not detected in the initial placebo-controlled trials leading to drug approval. The main point here is that these reports are not made in a systematic way, and the frequency of reports can be influenced by factors such as (a) the frequency of use of the drug (b) the novelty of the drug (c) media coverage of the drug and (d) efforts by the company to interact with users in a manner that will lead to them hearing of and therefore being required to report on AEs.

With these factors in mind, here are some of the problems with the ISMP report:

1. The report fails to consider the frequency of the use of the drug when considering the number of adverse events being reported. Since its launch in August 2006 (i.e. less than 2 years), Chantix has been used by an estimated 5.5 million smokers in the United States. In 2007 alone it was used by 3.8 million new patients in the U.S. (6.2 million prescriptions). This is many times more than the other drugs listed in the ISMP report. For example, Etanercept (Enbrel, the drug with the 3rd largest number of adverse event reports to FDA) was launched in 1998, and has been used by a total of 450,000 patients WORLDWIDE in those 10 years. Comparing frequency of adverse events without adjusting for the frequency of drug use is so obviously inappropriate as to cast doubt on the reliability of the report as a whole.
As mentioned briefly in the ISMP report, many factors can affect the frequency of reporting of adverse events to FDA. In the case of Chantix, the widely publicized death of a rock musician (who was tragically shot by a neighbor in Texas) which his partner felt could have been related to Chantix, sparked off widespread media speculation about potential side effects. The manufacturer also offers a number of direct to consumer quit smoking services, including a free telephone hotline called “Get Quit”. Because this hotline is run by the manufacturer, whenever a caller mentions a symptom, they are immediately transferred to the medical department, the details are noted and the information reported to FDA. These events and procedures can have a large effect of increasing the number of serious adverse events reported and this was not adequately considered in the ISMP report. It is noteworthy that 92% of the events analyzed in the ISMP report came via the manufacturer.

2. The report fails to adequately consider the possibility that some of the reported adverse events may have been caused by nicotine withdrawal. The vast majority of those using Chantix were attempting to quit smoking, which itself is known to cause a range of nicotine withdrawal symptoms, including many of the symptoms most commonly reported to FDA and mentioned in the ISMP report (depression, insomnia, anxiety, weight increase). It is entirely plausible that many of these reported symptoms were caused by nicotine withdrawal rather than Chantix. In fact in the placebo-controlled trials of Chantix, withdrawal symptoms were REDUCED in those using Chantix.

3. The report doesn't adequately consider the serious health effects of tobacco dependence. The ISMP report characterizes the other comparison drugs as being “intended for serious illness in patients and have benefits that are accompanied by substantial risks. In comparison, varenicline is intended for use in healthy people to help stop smoking.” Unfortunately this statement indicates a misunderstanding of the nature of tobacco dependence as a serious illness causing the premature death of 50% of continuing smokers, and of the fact that a high proportion of patients using smoking cessation medications are already suffering from or at very high risk for smoking-caused illnesses, including some mentioned as adverse events in the report (e.g. cardiac arrhythmias).

4. The report inaccuratley characterizes the relative efficacy of varenicline versus other treatments. The ISMP report states that Chantix has similar long term quit rates to nicotine gum. This statement contradicts the findings of the new US Public Health Service Clinical Practice Guideline on Treating Tobacco Use and Dependence, which found a mean quit rate of 13.8% with placebo, 19% with nicotine gum and 33.2% with varenicline (p109) and that quit rates with varenicline are significantly greater than with the nicotine patch (p121). This Guideline, written after the recent labeling changes for varenicline, concluded that, “Varenicline is an effective smoking cessation treatment that patients should be encouraged to use.” (p113).

Probably the most basic problem with the ISMP report is its failure to consider the frequency of use of the medicines as a factor influencing the interpretation of the frequency of adverse events reported. It therefore remains unclear whether any of these serious adverse events were caused by varenicline. When added to the other problems of interpretation mentioned above, I prefer to rely on the recommendation of the US Clinical Practice Guideline, which resulted from a very thorough review of the available scientific evidence.

So what does this mean for patients considering quitting smoking? As always, rely on the advice of your own doctor rather than on reports in the media or the internet (including this one!).

The complete ISMP report can be found at:
Strong Safety Signal Seen for New Varenicline Risks
http://www.ismp.org/docs/vareniclineStudy.asp

Previous posts on this blog that are relevant to this issue are:
What is nicotine withdrawal syndrome? 3/6/07http://www.healthline.com/blogs/smoking_cessation/2007/03/what-is-nicotine-withdrawal-syndrome.html
Ten tips for coping with nicotine withdrawal. 3/7/07http://www.healthline.com/blogs/smoking_cessation/2007/03/ten-tips-on-coping-with-tobacco.html
Chantix: how does this new stop smoking medicine work? 4/15/07http://www.healthline.com/blogs/smoking_cessation/2007/04/chantix-how-does-this-new-quit-smoking.html
Can quitting smoking trigger depression? 6/16/07http://www.healthline.com/blogs/smoking_cessation/2007/06/can-quitting-smoking-trigger-depression.html
Chantix and mental illness. 08/12/07http://www.healthline.com/blogs/smoking_cessation/2007/08/chantix-and-mental-illness.html
Two new studies of Chantix (varenicline). 08/19/07http://www.healthline.com/blogs/smoking_cessation/2007/08/two-new-studies-of-chantix-varenicline.html
Does Chantix cause mental health problems? 9/20/07http://www.healthline.com/blogs/smoking_cessation/2007/09/does-chantix-cause-mental-health.html
Chantix (varenicline) safety being reviewed by FDA. 11/21/07http://www.healthline.com/blogs/smoking_cessation/2007/11/chantix-varenicline-safety-being.html
New study of Chantix in comparison with NRT. 11/28/07http://www.healthline.com/blogs/smoking_cessation/2007/11/new-study-of-chantix-in-comparison-with.html
Smoking and suicide. 4/22/08 http://www.healthline.com/blogs/smoking_cessation/2008/04/smoking-and-suicide.html

Full reports on the largest placebo-controlled trials of varenicline can be found via:
http://jama.ama-assn.org/cgi/content/full/296/1/47

Labels: cessation, champix, Chantix, cigarette smoking, jonathan foulds, Nicotine Replacement, safety, varenicline

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Become an Ex

On previous posts I’ve talked about good websites for helping smokers quit:

Can smoking cessation internet sites help you to quit? 4/21/07
http://www.healthline.com/blogs/smoking_cessation/2007/04/can-smoking-cessation-internet-sites.html

There are quite a few good ones, and so far my favorite is at www.quitnet.com .

But I recently checked out a fairly new one and was very impressed. Its at www.becomeanex.org . It has been funded by a coalition on public health agencies, and appears to have been really well put together and is really easy to use. One of its main selling points is its emphasis on quitting smoking as a process, and its recognition that it is not all over in a month. So this site presents quitting as a process, provides loads of useful tips and advice, and is particularly good at helping you link with networks of other smokers for added support. The site makes good use of new technologies to make it easy to register, easy to communicate with other smokers trying to quit, and fairly easy to ask a question not just of others trying to quit, but also of recognized experts, like Dr Richard Hurt of the Mayo Clinic.

I found it very simple to register. You can set up your own profile, add your photo and details if you want (or not if you don’t), and there are plenty of subgroups you can join, made up of people with a particular thing in common (e.g. living in Texas, or using Chantix). The only slight problem I had was that when I clicked on some of the video components they didn’t all run smoothly. That may have just been a problem with my PC as I’m a bit technologically challenged. I believe this site is fairly new, (launched March, 2008) but I think it looks like it could be very helpful to tobacco users thinking about quitting.

Check it out and let me know what you think.
www.becomeanex.org

Labels: becomeanex, cessation, cigarette smoking, jonathan foulds, website

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New study compares Chantix to the nicotine patch

We have already talked about the studies showing that Chantix (varenicline or Champix outside the US) is more effective than both placebo pills and Zyban (bupropion) for smoking cessation. There has also been one study comparing smoking cessation outcomes before and after Chantix was available (by John Stapleton and colleagues in the UK).

Today a new study has been published comparing the effects of a standard course of Chantix (12 weeks) with a normal course of the nicotine patch (10 weeks) for stopping smoking. This was a randomized “open-label” study, meaning that neither the participants nor the researchers were able to choose which participants got which treatment, (they were allocated to treatment on the basis of random numbers), but that everyone new which treatment they got (i.e. there were no placebo or dummy patches or pills).

The study by Aubin and colleagues was carried out across 5 countries (Europe and USA), with 376 smokers being assigned to Chantix and 370 to the patch. All the participants smoked at least 15 cigarettes per day (average = 23 per day). The participants were required to be relatively healthy with no unstable illnesses within the previous 6 months (including psychological problems or substance dependence). None had used nicotine replacement therapy in the previous 6 months. About half (48%) had previously tried the nicotine patch, and almost 90% had previously tried to quit. The average age of participants was 43, and they had smoked for around 26 years. 93% of the participants were white.

Participants attended weekly appointments for the first 12 weeks, then had 7 further appointments up to the one year follow-up, as well as 5 telephone contacts.

3 months after the target quit date, 56% of those treated with Chantix had not used any tobacco during the prior month, as had 42% of those treated with the nicotine patch. This advantage for Chantix treatment was statistically significant. At the one year follow-up (i.e. after about 9 months without treatment medications) 26% of those allocated Chantix treatment remained remained quit, as did 20% of those treated with the patch (also a statistically significant difference). During the first 7 weeks of treatment, those treated with Chantix reported significantly lower craving, negative affect (bad mood) and restlessness.

About twice as many patients treated with Chantix (8%) as the patch (4.3%) had to discontinue the medicine due to an adverse event. The most frequent adverse events were nausea (37% on Chantix versus 10% on the patch), insomnia (around 20% in both groups) and headache (19% Chantix, 10% patch).

There has been some recent concern (discussed on this forum) about Chantix potentially causing depression and suicidal thoughts. In this trial, one person became depressed and it was believed to be caused by Chantix, and another person had suicidal thoughts (causing hospitalization) 11 days after completing Chantix treatment. These low rates of serious depression (<1%) in association with Chantix treatment are consistent with prior reports. It is interesting that ratings of “negative affect” were significantly lower among those taking Chantix than the patch during the first 7 weeks (meaning that Chantix users experienced, on average less bad moods/depressive thoughts than those wearing the patch). So the etiology of depression while taking Chantix remains a mystery. One possibility is that Chantix, because it is slightly more effective than prior medications, enables some people to successfully quit who would not otherwise have succeeded, and some of those people may be more prone to depression in association with quitting smoking.

Overall, the results from this study are consistent with previous studies in showing that Chantix is probably the most effective single medicine for smoking cessation, that it frequently causes mild side effects (e.g. transient nausea) and that serious adverse events are uncommon.

Ref:
Aubin HJ et al. Varenicline versus transdermal nicotine patch for smoking cessation: results from a randomized, open-label trial. Thorax published online Feb 8, 2008.

Labels: cessation, Chantix, cigarette smoking, jonathan foulds, Nicotine Replacement, patch, varenicline

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Planning to quit smoking with Chantix

We are currently approaching the peak “New Year” season for quitting smoking – also a time when people are very busy finishing off their year-end work and participating in the holiday season. As Chantix is the newest medication designed to help people quit, and will likely be heavily advertised by Pfizer – its manufacturer, I expect hundreds of thousand of people will use it for the first time over the coming months.

However, as we have discussed at length on this forum, some concerns have emerged regarding potential adverse events relating to use of this medicine: depressive or suicidal thoughts, aggressive or erratic behavior and drowsiness.
See link for prior discussions: http://www.healthline.com/blogs/smoking_cessation/2007/11/chantix-varenicline-safety-being.html

So is this a good drug that may help save your life or a dangerous drug that may harm you? As we’ve discussed before, the evidence is clear that Chantix is effective at helping smokers quit and is typically accompanied by fairly mild side-effects (e.g. mild nausea). The concerns are over the possibility that a very small minority of Chantix users (perhaps between 0.1 and 1%) may experience the more serious side-effects mentioned above. At the moment the FDA is investigating this, but so far there is no conclusive evidence that these side effects are caused by Chantix (rather than being rarely occurring effects of stopping smoking). I therefore recommend that smokers interested in quitting should not be scared to try Chantix as the drug really does help smokers quit. But I strongly recommend that smokers planning to use Chantix should ensure that they have organized a proper quit plan, utilizing a number of support networks (e.g. telephone quitline, family etc) but very much involving the family doctor also. By this I mean that rather than simply calling in to the doctor for a prescription (or ordering it on a website), you arrange an appointment with your doctor to discuss the use of the medicine, and its potential side-effects, and that you also arrange at least one follow-up appointment with him/her within the first two weeks of starting on the medicine. If a doctor who knows you and your medical history is supporting your quit attempt and monitoring your progress it is far less likely you will be seriously affected by these potential side effects, and more likely you will succeed in quitting.

This model of quitting smoking is also precisely what is recommended by the Clinical Pratice Guideline your doctor should be following (advising doctors on the “5 As”: Ask, Advise, Assess, Assist, Arrange)
http://www.tobaccoteacher.com/5As.html

So my recommendation for people thinking of trying Chantix in the near future is that you should start planning now. This would involve making an initial appointment to see your doctor, planning a target quit date (just over a week after your doctors appointment) AND arranging an additional follow-up appointment shortly after your quit date, so your doctor can monitor progress and give advice. These steps should be taken in addition to using other assistance such as telephone quitlines and internet sites for smoking cessation, enlisting the support of family and friends, and taking other sensible behavioral steps (e.g. throwing out all your remaining tobacco the night before your quit date).

Best of luck, and have a great holiday season.

Labels: cessation, Chantix, cigarette smoking, holidays, jonathan foulds, new year

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Helping Latino Smokers To Quit

Spanish speakers, primarily originating in Central and South America, are the fastest growing segment of the U.S. population. In the city where I work, (New Brunswick, New Jersey, USA) approximately 50% of the population is Latino – from a number of countries with Mexico being the largest subgroup. For various reasons, Latino smokers have been less inclined to make use of treatment services to help them quit. Here in New Brunswick we have worked at making our service more culturally competent, with the help of funding from the Robert Wood Johnson Foundation. This has included adding basic features (e.g. Spanish speaking staff), and doing more systematic outreach into the Latino community. In so doing the proportion of our patients who are Latino has increased from 3% in 2001 to over 15% in 2006. The website for this project includes resources for both smokers and clinicians at: http://proyectovidanofume.org/

Latino smokers are also even less inclined to use medication (like nicotine patches or Zyban) than the rest of the population, even when factors like health insurance coverage are the same. It seems that this is because some of the common misconceptions are even more prevalent in Latino smokers (e.g. “I should be able to quit on my own” or “These medicines may be as harmful as smoking”). In order to try to help remedy this situation we have translated guidance for consumers on the use of nicotine replacement therapy to Spanish. This and other documents are available at:
http://proyectovidanofume.org/espanol/publication-span.htm

Whether you live in Mexico, Manchester or Minneapolis, the message for smokers is the same: “The single best thing you can do for your health is to quit smoking. Help is available from your doctor, your pharmacist, and online and you should do whatever it takes to succeed in becoming tobacco free.”

Labels: cessation, cigarette smoking, latino, proyectovida

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Its Great American Smokeout

Tomorrow (November 15th, 2007) is the Great American Smokeout 2007 – a day on which smokers across the country are encouraged to try to go the whole day without using any tobacco - and then to consider staying that way.

There is usually a reasonable amount of media activity encouraging people to quit smoking and there is a national peak in quit attempts on this day. It is therefore an excellent day for smokers who have been contemplating quitting to have a go. If you are a regular reader of this blog, you’ll know that we’ve previously given a lot of advice on methods for stopping smoking. Some of the links are provided here to help you recap:

How bad is smoking for your health? 2/18/07
http://www.healthline.com/blogs/smoking_cessation/2007/02/how-bad-is-smoking-for-health.html

Ten tips for coping with nicotine withdrawal. 3/7/07
http://www.healthline.com/blogs/smoking_cessation/2007/03/ten-tips-on-coping-with-tobacco.html

Nicotine addiction: how it can trick you into “absent-minded” smoking. 4/13/07
http://www.healthline.com/blogs/smoking_cessation/2007/04/nicotine-addiction-how-it-can-trick.html

How to tell if a smoking cessation aid works. 4/29/07
http://www.healthline.com/blogs/smoking_cessation/2007_04_01_smoking_cessation_archive.html

Get rid of all your tobacco. 6/16/07
http://www.healthline.com/blogs/smoking_cessation/2007/06/get-rid-of-all-your-tobacco.html

Is nicotine replacement therapy effective in the “real world”? 6/21/07
http://www.healthline.com/blogs/smoking_cessation/2007/06/is-nicotine-replacement-therapy.html

When is the best time to quit smoking? 6/29/07
http://www.healthline.com/blogs/smoking_cessation/2007/06/when-is-best-time-to-quit-smoking.html

A year of smoking takes 3 months off your life. 7/9/07
http://www.healthline.com/blogs/smoking_cessation/2007/07/last-friday-july-6th-new-paper-was.html

The American cancer Society Website for Great American Smokeout is also worth a visit at: http://acsf2f.com/gaso/

I’d like to encourage all smokers out there to really have a go at lasting the whole of tomorrow without a smoke, whether you use a smoking cessation aid or not. Then if you can do it for one day, why not another?
I’d also love to hear from those who are going to try, what method you used, and how it went. Feel free to post your stories on this site for others to learn from. Best of luck.

Labels: cessation, cigarette smoking, great american smokeout

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Finding out about smoking and health

I’ve now been writing this blog for over six months and have noticed that some questions keep coming up that have been covered on a previous post. The site allows you to search for things and has a listing by month of topics, but I thought it might be helpful to post a full up-to-date list, with links attached. Most of these posts also have links to additional sources of information on the internet.

Jonathan Foulds’ posts on: www.healthline.com/blogs/smoking_cessation/

Introducing Dr Jonathan Foulds, 2/16/07
http://www.healthline.com/blogs/smoking_cessation/2007/02/introducing-dr-jonathan-foulds.html

How bad is smoking for your health? 2/18/07
http://www.healthline.com/blogs/smoking_cessation/2007/02/how-bad-is-smoking-for-health.html

3. Do women find it harder to quit smoking? 2/24/07
http://www.healthline.com/blogs/smoking_cessation/2007/02/do-women-find-it-harder-to-quit.html

Tobacco industry found guilty of racketeering. 2/25/07
http://www.healthline.com/blogs/smoking_cessation/2007/02/tobacco-industry-found-guilty-of.html

Why “lights” are just as deadly. 2/28/07
http://www.healthline.com/blogs/smoking_cessation/2007/02/why-lights-are-just-as-deadly.html

What is nicotine withdrawal syndrome? 3/6/07
http://www.healthline.com/blogs/smoking_cessation/2007/03/what-is-nicotine-withdrawal-syndrome.html

Ten tips for coping with nicotine withdrawal. 3/7/07
http://www.healthline.com/blogs/smoking_cessation/2007/03/ten-tips-on-coping-with-tobacco.html

Cold Turkey – 1. 3/18/07
http://www.healthline.com/blogs/smoking_cessation/2007/03/cold-turkey-1.html

Cold Turkey – 2. 3/18/07
http://www.healthline.com/blogs/smoking_cessation/2007/03/cold-turkey-2.html

“Lost” and FDA regulation of tobacco. 3/22/07
http://www.healthline.com/blogs/smoking_cessation/2007/03/lost-and-fda-regulation-of-tobacco.html

Quitting smoking while living with a smoker. 3/25/07
http://www.healthline.com/blogs/smoking_cessation/2007/03/quitting-smoking-while-living-with.html



Nicotine addiction: how it can trick you into “absent-minded” smoking. 4/13/07
http://www.healthline.com/blogs/smoking_cessation/2007/04/nicotine-addiction-how-it-can-trick.html

Chantix: how does this new stop smoking medicine work? 4/15/07
http://www.healthline.com/blogs/smoking_cessation/2007/04/chantix-how-does-this-new-quit-smoking.html

How about quitting smoking with someone else? 4/15/07
http://www.healthline.com/blogs/smoking_cessation/2007/04/what-about-quitting-smoking-with.html

Telephone quitlines: do they help smokers to quit? 4/19/07
http://www.healthline.com/blogs/smoking_cessation/2007/04/telephone-quitlines-do-they-help.html

Can smoking cessation internet sites help you to quit? 4/21/07
http://www.healthline.com/blogs/smoking_cessation/2007/04/can-smoking-cessation-internet-sites.html

17. How to tell if a smoking cessation aid works. 4/29/07
http://www.healthline.com/blogs/smoking_cessation/2007_04_01_smoking_cessation_archive.html

18. Facing the tobacco industry. 5/12/07
http://www.healthline.com/blogs/smoking_cessation/2007/05/facing-tobacco-industry.html

19. Facing the tobacco industry -2. 5/18/07
http://www.healthline.com/blogs/smoking_cessation/2007/05/facing-tobacco-industry-2.html

20. How addicted are you to cigarettes? (1) 5/19/07
http://www.healthline.com/blogs/smoking_cessation/2007/05/how-addicted-are-you-to-cigarettes-1.html

21. How addicted are you? (2) 5/19/07
http://www.healthline.com/blogs/smoking_cessation/2007/05/how-addicted-are-you-2.html

22. Is there such a thing as a safer cigarette? 5/23/07
http://www.healthline.com/blogs/smoking_cessation/2007/05/is-there-such-thing-as-safer-cigarette.html



23. Institute of Medicine Report: Ending The Tobacco Problem -1. 5/26/07
http://www.healthline.com/blogs/smoking_cessation/2007/05/is-there-such-thing-as-safer-cigarette.html

24. Institute of Medicine Report: Ending The Tobacco Problem -2. 5/27/07
http://www.healthline.com/blogs/smoking_cessation/2007/05/institute-of-medicine-report-ending_27.html

25. The nicotine reduction strategy. 5/28/07
http://www.healthline.com/blogs/smoking_cessation/2007/05/nicotine-reduction-strategy.html

26. Effects of alcohol on smoking cessation – 1. 5/29/07
http://www.healthline.com/blogs/smoking_cessation/2007/05/effects-of-alcohol-on-smoking-cessation.html

27. Effects of alcohol on smoking cessation – 2. 5/29/07
http://www.healthline.com/blogs/smoking_cessation/2007/05/effects-of-alcohol-on-smoking-cessation_29.html

28. Think you don’t really smoke for nicotine? 6/2/07
http://www.healthline.com/blogs/smoking_cessation/2007/06/think-you-dont-really-smoke-for.html

29. Marlboro Snus: what is it? 6/10/07
http://www.healthline.com/blogs/smoking_cessation/2007/06/marlboro-snus-what-is-it.html

30. Why did Philip Morris’s new smokeless tobacco product (“Taboka”) deliver almost no nicotine? 6/12/07
http://www.healthline.com/blogs/smoking_cessation/2007/06/why-did-philip-morriss-new-smokeless.html

31. Get rid of all your tobacco. 6/16/07
http://www.healthline.com/blogs/smoking_cessation/2007/06/get-rid-of-all-your-tobacco.html

32. Nicotrol Nasal Spray: an effective treatment for the heavy smoker. 6/16/07
http://www.healthline.com/blogs/smoking_cessation/2007/06/nicotrol-nasal-spray-effective.html

33. Can quitting smoking trigger depression? 6/16/07
http://www.healthline.com/blogs/smoking_cessation/2007/06/can-quitting-smoking-trigger-depression.html


34. Its time for pictorial warnings on cigarette packs. 6/18/07
http://www.healthline.com/blogs/smoking_cessation/2007/06/its-time-for-pictorial-warnings-on.html

35. Which nicotine replacement therapy? 6/19/07
http://www.healthline.com/blogs/smoking_cessation/2007/06/which-nicotine-replacement-therapy.html

36. Whats the problem with Accomplia/rimonabant (Zimulti), the weight-loss drug that helps you quit smoking? 6/20/07
http://www.healthline.com/blogs/smoking_cessation/2007/06/whats-problem-with-accompliarimonabant.html

37. Is nicotine replacement therapy effective in the “real world”? 6/21/07
http://www.healthline.com/blogs/smoking_cessation/2007/06/is-nicotine-replacement-therapy.html

38. Higher nicotine intake per cigarette among African American smokers: is it a menthol effect? 6/26/07
http://www.healthline.com/blogs/smoking_cessation/2007/06/higher-nicotine-intake-per-cigarette-by.html

39. Cigarette brand preferences: start young and focus on 3 brands. 6/26/07
http://www.healthline.com/blogs/smoking_cessation/2007/06/cigarette-brand-preferences-start-young.html

40. Reductions in teen smoking. 6/26/07
http://www.healthline.com/blogs/smoking_cessation/2007/06/reductions-in-teen-smoking.html

41. Tobacco use around the world. 6/27/07
http://www.healthline.com/blogs/smoking_cessation/2007/06/tobacco-use-around-world.html

42. When is the best time to quit smoking? 6/29/07
http://www.healthline.com/blogs/smoking_cessation/2007/06/when-is-best-time-to-quit-smoking.html

43. Advice on using over-the-counter nicotine replacement therapy. 6/30/07
http://www.healthline.com/blogs/smoking_cessation/2007/06/advice-on-using-over-counter-nicotine.html

44. Wearing the patch prior to quitting may help. 7/1/07
http://www.healthline.com/blogs/smoking_cessation/2007/07/wearing-patch-prior-to-quitting-may.html

45. Celebrate your independence from tobacco. 7/4/07
http://www.healthline.com/blogs/smoking_cessation/2007/07/celebrate-your-independence-from.html

46. Tobacco and global warning. 7/7/07
http://www.healthline.com/blogs/smoking_cessation/2007/07/tobacco-and-global-warming.html

47. A year of smoking takes 3 months off your life. 7/9/07
http://www.healthline.com/blogs/smoking_cessation/2007/07/last-friday-july-6th-new-paper-was.html

48. Thanks to grand rounds 3.42. 7/13/07
http://www.healthline.com/blogs/smoking_cessation/2007_07_01_smoking_cessation_archive.html

49. 17th Surgeon General, Dr Richard Carmona, joins Healthline. 7/13/07
http://www.healthline.com/blogs/smoking_cessation/2007/07/17th-surgeon-general-dr-richard-carmona.html

50. How many cigarettes does it take to become addicted? 7/20/07
http://www.healthline.com/blogs/smoking_cessation/2007/07/how-many-cigarettes-does-it-take-to.html

51. How many medical doctors smoke? 7/22/07
http://www.healthline.com/blogs/smoking_cessation/2007/07/how-many-medical-doctors-smoke.html

52. Health insurance coverage for nicotine dependence treatment. 7/22/07
http://www.healthline.com/blogs/smoking_cessation/2007/07/health-insurance-coverage-for-nicotine.html

53. Increase cigarette tax to pay for children’s healthcare. 7/27/07
http://www.healthline.com/blogs/smoking_cessation/2007/07/increase-cigarette-tax-to-pay-for.html

54. Could smoking reduction improve your health? 7/27/07
http://www.healthline.com/blogs/smoking_cessation/2007/07/could-smoking-reduction-improve-your.html

55. Is cannabis smoking more harmful than cigarette smoking? 7/31/07
http://www.healthline.com/blogs/smoking_cessation/2007/07/is-cannabis-smoking-more-harmful-than.html



56. Thank you Health Business Blog for grand rounds 3:45. 8/2/07
http://www.healthline.com/blogs/smoking_cessation/2007/08/thank-you-health-business-blog-for.html

57. Menthol smokers inhale more toxins. 8/3/07
http://www.healthline.com/blogs/smoking_cessation/2007/08/menthol-smokers-inhale-more-toxins.html

58. Health effects of Tobacco Smoke Pollution. 8/6/07
http://www.healthline.com/blogs/smoking_cessation/2007/08/health-effects-of-tobacco-smoke.html

59. Sidestream cigarette smoke more toxic than mainstream smoke. 8/8/07
http://www.healthline.com/blogs/smoking_cessation/2007/08/sidestream-cigarette-smoke-more-toxic.html

60. Make yours a smoke-free home. 08/10/07
http://www.healthline.com/blogs/smoking_cessation/2007/08/make-yours-smoke-free-home.html

61. Chantix and mental illness. 08/12/07
http://www.healthline.com/blogs/smoking_cessation/2007/08/chantix-and-mental-illness.html

62. Two new studies of Chantix (varenicline). 08/19/07
http://www.healthline.com/blogs/smoking_cessation/2007/08/two-new-studies-of-chantix-varenicline.html

63. Thanks to Grand Rounds 3:47. 08/20/07
http://www.healthline.com/blogs/smoking_cessation/2007/08/thanks-to-grand-rounds-347.html

64. Getting through the first few weeks. 08/20/07
http://www.healthline.com/blogs/smoking_cessation/2007/08/getting-through-first-few-weeks.html

65. Carcinogens from smoking and smokeless tobacco use (1). 8/27/07
http://www.healthline.com/blogs/smoking_cessation/2007/08/carcinogens-from-smoking-and-smokeless.html

66. Smoking, smokeless tobacco and cancer (2). 8/28/07
http://www.healthline.com/blogs/smoking_cessation/2007/08/smoking-smokeless-tobacco-and-cancer-2.html



67. Do you (or your kids) hookah? 9/13/07
http://www.healthline.com/blogs/smoking_cessation/2007/09/do-you-or-your-kids-hookah.html

68. Stopping smoking effects on drug metabolism. 9/16/07
http://www.healthline.com/blogs/smoking_cessation/2007/09/stopping-smoking-effects-on-drug.html

69. Does Chantix cause mental health problems? 9/20/07
http://www.healthline.com/blogs/smoking_cessation/2007/09/does-chantix-cause-mental-health.html

70. Does it help to add nicotine gum to bupropion? 9/24/07
http://www.healthline.com/blogs/smoking_cessation/2007/09/does-it-help-to-add-nicotine-gum-to.html

71. Tobacco tax to renew insurance for poor kids. 9/24/07
http://www.healthline.com/blogs/smoking_cessation/2007/09/tobacco-tax-to-renew-insurance-for-poor.html

72. Effects of smoking during pregnancy. 9/28/07
http://www.healthline.com/blogs/smoking_cessation/2007/09/effects-of-smoking-during-pregnancy.html

73. State-specific prevalence of cigarette smoking. 9/30/07
http://www.healthline.com/blogs/smoking_cessation/2007/09/state-specific-prevalence-of-cigarette.html

Labels: cessation, cigarette smoking, health

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Effects of smoking during pregnancy

The harmful effects of smoking during pregnancy have been known for many years and in 2001 the US Surgeon General summarized the effects as follows:

-Smoking during pregnancy is associated with increased risk for premature rupture of membranes, abruptio placentae (placenta separation from the uterus), and placenta previal (abnormal location of the placenta, which can cause massive hemorrhaging during delivery). Smoking is also associated with a modest increase in risk for preterm delivery.

-Women who smoke may have a modest increase in risks for ectopic pregnancy and spontaneous abortion.

-Infants born to women who smoke during pregnancy have a lower average birth weight and are more likely to be small for gestational age than infants born to women who do not smoke. Low birth weight is associated with increased risk for neonatal, perinatal, and infant morbidity and mortality. The longer the mother smokes during pregnancy, the greater the effect on the infant’s birth weight.

-The risk for perinatal mortality, both stillbirths and neonatal deaths, and the risk for sudden infant death syndrome (SIDS) are higher for the offspring of women who smoke during pregnancy.

Most relevant studies suggest that infants of women who stop smoking by the first trimester have weight and body measurements comparable with those of nonsmokers’ infants. Studies also suggest that smoking in the third trimester is particularly detrimental.

Although less well known, there is also fairly good evidence of harmful effects on the child’s psychological development of smoking in pregnancy. A study published by Button and colleagues in the journal, “Early Human Development” this past week concluded that, “There is strong evidence for an association between maternal smoking in pregnancy and psychological problems in offspring. The problems most frequently associated are attention problems, hyperactivity, and conduct problems.” Although there are a number of explanations for this association, animal studies confirm a direct causal effect of toxin exposure on brain development during pregnancy.

The implications are very clear: there are massive benefits to the health of the mother and the baby of quitting smoking before or during pregnancy. The following link provides some good structured advice on quitting smoking in pregnancy:

http://www.surgeongeneral.gov/tobacco/prenatal.htm

Labels: cessation, cigarette smoking, pregnancy

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Does Chantix Cause Mental Health Problems?

The issue of Chantix effects on mental health gained national attention yesterday when the ABC News program “Good Morning America” covered the story of the bizarre and tragic death of the Texas musician, Carter Albrecht. http://www.abcnews.go.com/GMA/OnCall/Story?id=3623085&page=2

Some of the details of this tragedy can be found online via the ABC news story but the key points were that Mr Albrecht was actually killed by being shot in the head by a neighbor as he banged on the neighbor’s door, but that his girlfriend felt that his bizarre behavior may have been caused by the Chantix he was taking at the time.

Regular readers of this blog will know that this issue has come up before – see:
“Chantix: how does this new stop smoking medicine work?” 4/15/07
http://www.healthline.com/blogs/smoking_cessation/2007/04/chantix-how-does-this-new-quit-smoking.html

“Chantix and mental illness: what are the facts?” 08/12/07
http://www.healthline.com/blogs/smoking_cessation/2007/08/chantix-and-mental-illness.html

“Two new studies of Chantix (varenicline)”. 08/19/07
http://www.healthline.com/blogs/smoking_cessation/2007/08/two-new-studies-of-chantix-varenicline.html

There have been a number of comments from people who experienced frightening dreams, anxiety attacks, depression and suicidal thoughts while on the medicine, as well as the suicide of a family member. The number and pattern of these comments were sufficient to cause me some concern and so I decided to take another look at the published reports of the clinical trials of Chantix and also speak to a number of colleagues who treat many patients with Chantix, in order to try to get a sense of whether these experiences may be caused by Chantix, rather than other potential causes (including nicotine withdrawal effects).

On looking at the evidence from the clinical trials, it is more consistent with the idea that Chantix reduces depressive thoughts, rather than increases them. For example, one large study was published in JAMA on July 2006 comparing the outcomes of 352 smokers treated with Chantix (varenicline), 329 people treated with Zyban (bupropion) and 344 people treated with identical placebo pills. This was a randomized double-blind trial meaning that no-one knew which type of pills they received until the end. 22% quit completely for a year on Chantix, as did 16% on Zyban and 8% on placebo. The paper reported on changes in “negative affect” (a combination of unpleasant mood symptoms including depression and irritability). Patients on Chantix reported a significantly SMALLER increase in these symptoms than patients taking placebo. Zyban had a similar effect of reducing negative affect compared with placebo pills. The paper also listed adverse events reported by participants. The main symptom that was clearly reported more frequently by Chantix users was nausea, reported by 28% of Chantix users, compared with 13% on Zyban and 8% on placebo. Of the psychiatric disorders mentioned, only “abnormal dreams” appeared to be more common on Chantix (10%), compared with 6% on Zyban and 6% on placebo. There was no clear difference in reports of serious irritability (6%, 5%, 6%) and fewer patients on Chantix reported insomnia (14%) than did patients on Zyban (22%). In terms of “serious” adverse events, these were no more common for Chantix than placebo and the single case of a serious psychiatric event (acute exacerbation of schizophrenia) occurred in a patient taking placebo pills.

Another almost identical trial was reported by Jorenby and colleagues in the same issue of JAMA, with very similar results (i.e. higher quit rates with Chantix, along with lower reported negative affect [mood] than placebo, but higher rates of nausea.). Serious adverse events again were rare and scattered evenly across the different types of pills with little clear pattern, but there was one report of “acute psychosis, emotional lability” in the Chantix group (out of 344 taking Chantix). This study did, however, find a higher rate of “abnormal dreams” on Chantix (13%) than Zyban (6%) or placebo (4%). The earlier studies designed to identify the best dose of Chantix also had similar findings (dose-dependent increase in nausea and abnormal dreams) but no real evidence of other mental health symptoms. For example, Nides and colleagues found 10% on placebo and 12% on the high dose of Chantix reported serious “irritability’, and that “depression was not observed as an adverse event with varenicline (Chantix) treatment.”

The data sheet for prescribers of Chantix notes that 4500 people were exposed to Chantix during its premarketing development and that discontinuation of treatment due to adverse events was rare. The most frequent reason was nausea (3% for Chantix versus 0.5% for placebo). 0.3% reported discontinuing Chantix because of abnormal dreams as did 0.2% on placebo pills. As with all medications, the data sheet has a long list of symptoms experienced by participants in the trials, including “Psychotic disorder, suicidal ideation” as “rare”. Note – this does not imply that the drug caused these events – just that they occurred rarely in people taking the drug. Overall, the pattern of results from trials of Chantix suggest that with the exception of abnormal or vivid dreams, psychiatric symptoms such as depression or negative affect are LESS likely to occur in people taking Chantix to quit smoking, than in people taking placebo pills while quitting smoking.

However, one has to bear in mind that early clinical trials typically exclude patients currently being treated for mental health and other serious health problems. So the possibility remains that the drug may cause problems in types of patients that were not included in the initial trials. That’s where post-marketing surveillance is important. This is something that the pharmaceutical companies and doctors routinely carry out. For my part, I simply asked a large group of colleagues who are experienced in treating “real patients” with Chantix and other treatments, whether they had noticed any signs of worsening mental health associated with Chantix use. The clinicians I spoke to estimated that they had been involved in the treatment of over 2000 patients with Chantix, including patients with co-occurring serious mental health and other medical problems. There was a pretty clear consensus that while there were a few isolated cases (a couple) of patients reporting mental health problems, these were not noticeably more frequent than one normally encounters with other treatments (e.g. nicotine replacement or Zyban, or counseling with no medication).

So overall I am somewhat reassured that Chantix is a safe medicine that is effective at helping smokers to quit. But why the rash of reports on the internet of depression and bizarre behavior? Firstly, I don’t doubt that these people’s experiences are real and in some cases, very serious. I also think it is plausible that some (probably a minority) could be directly linked to Chantix. In some cases it could be an unusual interaction between the individual, the medicine and maybe another drug (including alcohol) they are taking. But for most, I suspect the serious behavioral/psychiatric problems experienced are unlikely to be caused by Chantix. Here are my reasons:
1. For highly addicted smokers, mood disturbance and altered thinking is common when quitting smoking, even without taking any medication.
2. The evidence described above, indicates that with the exception of abnormal dreams, Chantix reduces the severity of mood/psychological disturbance experienced while trying to quit smoking.
3. Around 3 million Americans have taken Chantix to try to quit smoking. Among that many smokers trying to quit for a month or two, one would expect a few thousand or more to have serious symptoms of depression etc even if they were not taking a medicine to help them. But when someone has these symptoms while taking a new drug, it is perfectly natural to conclude that the drug may have caused the symptom. In these days of widespread internet access, chat-rooms etc, that easily turns into a few hundred patients reporting similar symptoms on the internet while taking the same drug.

It therefore appears that if Chantix causes any serious mental health problems at all (which remains unproven), it is extremely rare (perhaps in the order of one per thousand). So my advice is that if you are considering quitting smoking and are interested in taking an FDA-approved medicine, whether it be nicotine replacement therapy, bupropion or Chantix, then you should not be put off by relatively isolated reports of side effects. The highest quality of evidence (from randomized placebo-controlled trials) demonstrates that these medicines are safe and will roughly double your chances of successfully quitting smoking. However, everyone reacts to medicines differently, and if you start to experience a worrying symptom that you believe may be caused by the medicine you should consult your doctor immediately. Even better, when you see your doctor to obtain a prescription, you should arrange a follow-up visit within a week or so of starting the medicine in order to discuss your progress, side-effects etc. If you have any concerns between appointments, call your doctor. It is also wise to get as much additional support from friends, family, telephone quitlines etc as possible. There is a national (US) toll-free number for telephone counseling (1-877-448-7848) and in the case of Chantix users in the US, there is additional support available via http://www.chantix.com/ .

Finally, anyone who believes there to be a causal link between use of a medication and a severe adverse event (e.g. depression, suicidal ideation, suicide, or any other serious adverse event), whether it be in yourself, your patient or a family member, should report it to the MedWatch program at: http://www.fda.gov/medwatch/how.htm . This is one of the main mechanisms of post-marketing surveillance that can help identify rare or previously unknown risks from medicines.

Labels: cessation, Chantix, cigarette smoking, varenicline

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Stopping smoking effects on drug metabolism

It is widely known that smoking speeds up basal metabolic rate (by around 10%) and so stopping smoking slows down the basal metabolic rate. This is one of the reasons people tend to put on weight when they stop smoking (the other reason is increased appetite resulting from the loss of nicotine’s mild appetite suppressant effects).

However, it is less widely known that cigarette smoking increases the activity of several liver enzymes that are responsible for metabolizing a number of drugs/medicines. This means that smokers frequently require a larger dose of these medicines than non-smokers, and may require the dose to be reduced after they quit smoking. One of the drugs whose metabolism is affected by smoking is caffeine. So when someone who drinks 6 cups of caffeinated coffee per day stops smoking, those 6 cups will produce blood caffeine levels up to 50% higher and so they will therefore feel as if they had about 9 cups of coffee. In the case of caffeine this could cause the person to feel anxious, restless and jittery and may also make it harder to get to sleep.

Many of the medicines that are affected by smoking are medicines used to treat psychiatric problems. These include some members a class of antianxiety drugs known as, “benzodiazepines” (e.g. diazepam), a number of anti-psychotic medicines (including some of the newer “atypical” anti-psychotic medicines e.g. olanzapine (Zyprexa), as well as older ones like haloperidol [Haldol]). Metabolism of some antidepressants is also affected in a similar way as are some other (non psychiatric) medicines. So, as with caffeine, when people who are already taking these medicines on a regular basis then quit smoking, the blood levels of these medicines may well increase by 10-40%. So depending on the medicine, this may also cause an increase in some of the side-effects caused by the medicine.

All of this serves to underline that it is a good idea to speak to your family doctor around the time you plan to quit. The family doctor should be able to identify the medicines whose metabolism is affected by tobacco, and also identify the likelihood that any new side effects that begin after ceasing smoking may be due to the effects on drug metabolism.

A list of drugs whose metabolism is known to be affected by smoking (and therefore smoking cessation) may be found at: http://smokingcessationleadership.ucsf.edu

Labels: cessation, cigarette smoking, drugs, metabolism

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Two new studies of Chantix (varenicline)

Two new trials of the smoking cessation medicine varenicline (Chantix) were published this past weekend. One reported the results in 515 nicotine-dependent Japanese smokers (mainly men) and the other reported the results in 250 Korean and Taiwanese smokers.

The Japanese study compared the outcomes across various doses of varenicline, with participants taking the pills for 12 weeks, and then being followed up for a further 40 weeks off drug. As in previous studies, the 1mg dose (twice daily) achieved slightly higher quit rates than lower doses, albeit with higher reported side-effects. The 1mg dose achieved abstinence rates of 65% at 12 weeks, as compared with 40% among those using placebo pills. At one year follow up, 35% of those who were given 1mg pills for the first 12 weeks remained abstinent, compared with 23% of those who had taken placebo pills. So this study in Japan confirmed the safety and efficacy of Chantix, but the “effect size” – the degree to which the drug performed better than placebo, was not quite as impressive as previous studies. This was partly because a relatively large proportion of Japanese smokers in this study succeeded in quitting while using placebo pills.

Another study based in Korea and Taiwan directly compared 12 weeks of 1mg varenicline with 12 weeks of placebo in 250 smokers (mainly men). After 12 weeks, 60% of those using varenicline were not smoking, compared with 32% of those using placebo pills. After 24 weeks (i.e. another 12 weeks “off drug”) the quit rate was 47% among those who had used varenicline, versus 22% among those who had used placebo. As in previous studies, those taking varenicline were more likely to report some nausea, constipation and abnormal dreams, but these were generally mild in nature. Also like prior studies, those on Chantix were not less likely to report an increased appetite. This is noteworthy as most previous smoking cessation medicines (such as nicotine replacement therapy or bupropion) tend to reduce appetite compared with placebo, and suggests that Chantix works via a slightly different mechanism.

So far, the placebo-controlled trials of varenicline have been remarkably consistent in finding that it approximately doubles quit rates compared with placebo, and that this increased quit rate is maintained even after up to 40 weeks off drug. The early studies suggested that Chantix may result in higher quit rates than other pharmacological treatments for smoking. Whether this ultimately turns out to be the case will require additional studies directly comparing different treatments.

The take-home message for smokers interested in trying to quit is that this new medicine continues to demonstrate that it is safe and effective in increasing smokers’ chances of successfully quitting, with the most frequent side-effect being mild nausea (16-42% of users). The nausea is less marked at lower doses, and also appears less when taking the pill along with food and water. Most people using Chantix are able to continue using it and the initial nausea subsides. Those continuing to take Chantix for the full course (up to 24 weeks) tend to have higher quit rates than those discontinuing early.

Labels: addiction, cessation, Chantix, cigarette smoking, nicotine, tobacco, varenicline

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Health insurance coverage for nicotine dependence treatment

Last night I went to see the Michael Moore movie “SiCKO” which is an expose of the problems with the U.S. healthcare system, focusing particularly on the problems with health insurance and so-called “Health Maintenance Organizations (HMOs)”. No matter what you think of Michael Moore, if you have any interest at all in your health or that of your family, and particularly if you have any interest in this nation’s health, then you should definitely see this movie.

The movie points out some of the worst aspects of the health insurance system and then compares it to the situation in countries like Canada, the UK, Cuba and France. As someone who has been both a patient and a provider in the UK and US healthcare systems I have to say I found the portrayal in the movie to be very accurate. The United States is a great country with tremendous wealth both financially and in terms of the resilience and hard work of its people. But to my mind its healthcare system is nothing short of a national disgrace. There are many areas of business in which the free market works best, but healthcare is just not one of them. A clear example of this is the existence of hundreds of doctors and other professionals employed by HMOs basically to devise reasons to deny coverage and save the company money. A number of ex HMO employees in the movie explained that they would receive bonuses based on the proportion of denials of care/coverage the achieved, setting up a bizarre situation where staff are given incentives to provide less care for sick patients.

I suspect that unless you or your family have never been sick, or you are fortunate to have good coverage through your employer, and not to have suffered from one of the numerous illnesses that are not covered, then you won’t need any further evidence from Michael Moore or myself to know that the U.S. system is entirely broken. But you may be living under the false impression that despite its problems, the U.S. system is better than most other comparable places. As the movie shows, citizens in many other (poorer) countries have access to high quality medical care 24-7 at no (or minimal) direct cost. Doctors are able to provide healthcare according to need rather than according to individual ability to pay. Moore’s portrayal is supported by cross-national surveys on the satisfaction of citizens with their health system, in which Canada and the European nations have consistently earned higher marks than has the U.S. system. Part of the problem is that U.S. healthcare is more expensive, it treats patients more intensively (overtreats?), and it is very inefficient. So the very things that a free market is supposed to be good at (achieving lower prices and higher efficiencies via competition) do not work for healthcare. Why is this? Well part of the problem (in my humble opinion) is that some rather dim-witted people have continued to base their design of the system on ideology rather than a careful but common-sense analysis of how healthcare actually works. Take the example of a medium-sized city, - say 100,000 adults with another 100,000 in a 50-mile radius. Such a city will typically have one medium sized hospital, and just about enough medical personnel to cover most (but maybe not all) specialties. The idea of letting the market compete for best value healthcare in that (fairly typical) city is clearly ridiculous. The provider has a monopoly. In some places the health insurance company may also have a virtual monopoly. Add to the mix you as an individual developing a life-threatening illness and you really do not have a situation in which the free market system is likely to work well. So you don’t have many of the most important potential advantages of a market-based system, but you do have the disadvantages of businesses (including the doctors, hospitals, insurance companies etc) seeking to maximize profit. In the end it’s the patient that suffers.

In addition to the disadvantages of the U.S. system described above and shown in the movie, to me there is one very basic thing about the psychology of illness that makes this system bad. If ever there was a time in your life that you really don’t want to have financial worries, it’s when you or a loved one is sick. The system we have in the United States is designed to maximize financial stress whenever we get sick. Everyone in this country, except perhaps the very rich, has to live with the concern that if we are unlucky enough to get a serious illness that is expensive to treat, then everything we have built for our family is at risk, not just because of the illness but because of the cost of getting it treated. In most other comparable countries of the world, the people just have to worry about the illness, not the cost of treating it.

As you may have gathered, this is one of those topics (like global warming) that is much bigger and more important than my specific area of interest: tobacco and health. But I see on a daily basis how the U.S. system does not work well with smoking cessation. Counseling smokers and providing them with an effective smoking cessation medicine is one of the most cost-effective healthcare interventions available. But most healthcare providers cannot get paid by the insurance systems for providing such interventions and most patients cannot get the costs of their treatment covered by their insurance. If you are lucky, your health insurance will pay for your coronary artery bypass operation caused by your smoking, or for your operation and chemotherapy to treat your lung cancer. Most likely this could all have been avoided if your insurance had covered your smoking cessation treatment(s) in the first place. Instead your insurer is employing staff whose job it is to think up ways to deny you coverage: “we don’t cover over-the-counter treatments like the patch”, “we don’t cover preventive interventions”, “you have $200 per year for preventive care, but having your blood pressure measured at your last visit used that up”, “there are no tobacco treatment specialists in our network”, “your policy has a $500 deductible for preventive or behavioral interventions and smoking cessation is valued at $499”, “we don’t have a diagnosis or procedure code for smoking cessation” etc etc…” but we CAN send you a leaflet that tells you how bad smoking is for your health”!

So I’d recommend that you check out the movie and let me know what you think. If you managed to get help to quit smoking provided or paid by your health insurance, I’d love to hear about it. It’s always nice to hear about the times/places where the system works well. When you are considering who to vote for in the forthcoming elections, please check out the detail of their policy on health insurance, and also find out how big a contribution they accepted from (a) Big Pharma (b) Big Managed Care and (c) Big Tobacco. By doing that and voting for candidates who appear likely to do the best job on healthcare, we might get some much-needed change.

Labels: cessation, health-insurance, HMO, michael moore, nicotine addiction cigarette smoking tobacco, sicko, treatment

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A Year of Smoking Takes 3 Months Off Your Life

Last Friday (July 6th) a new paper was published in the British Medical Journal by two British experts on smoking cessation: Dr Paul Aveyard and Professor Robert West. That paper primarily aimed to inform health professionals of the best ways to help their patients quit smoking. While the report contained many points that readers of this blog will be familiar with, there were a few new points (for me anyway) that are worth highlighting.

The first thing that struck me was the statement that, “Every year that smoking cessation is postponed after the age of 40 reduces life expectancy by three months.” Although the health effects of smoking are many and varied, that simple statement summarizes the evidence in a simple but impactful way. You might ask, “So what is that based on?” The citation for the statement is the 50-year follow-up study of 40,000 male British doctors, published by Sir Richard Doll and colleagues. That study found that although smokers who quit by age 35-40 were likely to live about as long as never smokers, those who continued to smoke typically died 10 years younger than never smokers. Someone who quits at age 35 is therefore likely to live to be around 85, whereas if that person continues to smoke they are more likely to die at around 75. So if that extra 40 years of smoking costs you 10 years of life, that’s consistent with losing 3 months for every year of smoking.

The authors also presented some data on the likelihood of a person succeeding in quiting smoking by age 50, assuming they try once a year starting at age 35. If the smoker just tries on their own each year, without any special assistance, there’s about a 50% chance they’ll be quit by age 50. If they use an FDA-approved smoking cessation medication each quit attempt (e.g. nicotine replacement or Chantix), there’s about a 75% chance they’ll be quit by age 50. If they use an approved cessation medication and get specialist counseling with each quit attempt, there’s about a 95% chance they will have succeeded in quitting, for good by age 50.

Now, given that by delaying success in quitting smoking from age 35 to 50 will already have cost a few years in life expectancy, I’d advise all smokers to go directly for the most effective treatment (counseling plus meds), and if it doesn’t work first time just keep trying until it does. If you use recommended treatment and keep trying to quit, the chances are very high you’ll succeed in quitting for good within the next 15 years.

The Aveyard and West paper can be downloaded from: http://www.bmj.com/cgi/content/full/335/7609/37

Best of luck.

Labels: cessation, nicotine addiction cigarette smoking tobacco

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Wearing the patch prior to quitting may help

If you buy a box of nicotine patches, you will notice that the instructions for use and warnings advise against wearing the patch while taking nicotine from any other source. Many smokers interpret this as implying that something terrible will happen if they kept the patch on while smoking, and consequently when they have a lapse cigarette then often decide to take the patch off (and so obey the instructions on the box).

However, numerous studies have shown that nothing terrible happens when you smoke while wearing the patch. 15 years ago I published a study in which 30 smokers smoked normally for 2 weeks, and wore full strength nicotine patches for one of those weeks and placebo patches for the other. The smokers generally couldn’t tell which week was the week with the nicotine patches and the single participant who vomited did so while wearing placebo patches! So it appears to be very unlikely for smokers to experience adverse events caused by wearing the patch while smoking.

However, some recent studies have actually suggested that wearing the patch for a few weeks prior to the target quit date may actually increase the chances of a successful quit. One such study was carried out by Dr Schuurmans and colleagues in South Africa. They found that people who wore nicotine patches for two weeks prior to their quit day had better long term quit rates than smokers who wore placebo patches for two weeks prior to their quit date (22% vs 12% quit, 6 months later).

Interestingly, studies of the use of other forms of nicotine replacement therapy by smokers not intending to quit have also found that not only does the NRT help them to reduce their cigarette consumption, but that a significant proportion of them go on and quit completely. One such study was carried out by Dr Batra and colleagues in Germany. They recruited over 300 smokers who were interested in cutting down but not quitting. They were provided with either 4mg nicotine gum or placebo gum for a year. As well as helping with smoking reduction, the group receiving the nicotine gum had significantly more people who were quit 13 months later (12% versus 5%).

We are not clear on the mechanism whereby combining NRT with smoking prior to quitting may help subsequent cessation. It may simply be that it loosens the associations between smoking and reinforcement (by providing nicotine separately from smoking). Just to be clear, the use of NRT prior to the quit date is not yet normal practice, and may never become so. My current practice is to advise patients using the patch to put their first patch on the morning of their quit day and not before (as suggested on the box). However, as more evidence is gathered on the safety and effectiveness of NRT pre-treatment, I may have to reconsider.

Labels: cessation, nicotine, pre-treatment, replacement, Smoking

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Advice on using over-the-counter nicotine replacement therapy.

Surveys have shown that many smokers (incorrectly) do not believe that nicotine replacement therapy helps smokers to quit. Many also believe NRT can cause cancer (again incorrectly). Unfortunately the labeling on the NRT product packaging also uses very cautious language that reinforces the idea that NRT can be dangerous. For examples, the long list of precautions regarding co-occurring medical problems, the advice to use low doses unless you are a heavy smoker, and the advice against using the NRT if you smoke or use another NRT, all feed the perception that NRT is dangerous and should be avoided if at all possible.

Partly because of these miscommunications to the public, only a fraction of those trying to quit smoking use an effective smoking cessation aid and even fewer use it in an optimal manner for smoking cessation. In order to help improve this situation, Professor Lynn Kozlowski (University of Buffalo) and a group of experts in smoking cessation have produced a paper discussing these issues, and (importantly) providing a consensus statement on the most effective way to use NRT. The summarized version of the agreed-upon advice to consumers is provided below:



1. NRT is one good tool to help you quit smoking. But NRT can’t do all the work for you—you have to help—and it is not the only tool to help you stop smoking.


2. Don’t worry about the safety of using NRT to stop smoking: NRT is a safe alternative to cigarettes for smokers.


3. Do be cautious about using NRT while pregnant.


4. NRT is less addictive than cigarettes and it is not creating a new addiction


5. Stop using NRT only when you feel very sure you can stay off cigarettes.


6. If the amounts of NRT you are taking do not help you stop smoking, talk with your health care provider about using (1) more NRT, (2) more than one type of NRT at the same time, (3) other smoking cessation medicines at the same time, or (4) telephone or in person advice on quitting tips.


7. If NRT helps you stop smoking, but you go back to smoking when you stop using NRT, you should seriously think about using NRT again the next time you try to stop smoking.


8. Make sure you are using the gum or lozenge in the best way:
o Chew the gum slowly – fast chewing doesn’t allow the nicotine to be absorbed from the lining of the mouth and can cause nausea.
o Don’t drink anything for 15 minutes before and nothing while you are using nicotine gum or the lozenge so your mouth can absorb the nicotine.
o Make sure you get the right amount of nicotine – people who smoke more than 10 cigarettes per day should use a 4mg piece of gum or lozenge.


9. Make sure you are using the patch in the best way:
o If you can’t stop having a few cigarettes while using the patch, it is best to keep the patch on. Don’t let a few slips with cigarettes stop you from using the patch to quit smoking.
o You may need to add nicotine gum or lozenges to help get over the hump or you may need to use more than one patch at a time. Talk to your healthcare provider about this.


10. If the price of NRT is a concern, try to find “store brand” (generic) NRT products which are often cheaper than the brand name products.

11. Do whatever it takes to get the job done—it is not a weakness to use medicine to stop smoking.

Adapted from: Kozlowski LT, .Giovino GA, Edwards B, DiFranza J, Foulds J, Hurt R, Niaura R, Sachs DPL., Selby P, Dollar KM., Bowen D Cummings KM, Counts M, Fox B, Sweanor D, Ahern F. Advice on using over-the-counter nicotine replacement therapy- patch, gum, or lozenge- to quit smoking. Addictive Behaviors (in press).

Some of these pieces of advice contradict some of the advice given on the product packaging (e.g. suggestion to combine NRTs and to continue use until confident of quitting). However, this advice is based on the latest research evidence and the clinical expertise of 16 experts on tobacco treatment.

You can read the full paper and a Spanish translation of the key points at:
http://proyectovidanofume.org/publication.htm

Labels: aid, cessation, nicotine, nicotine addiction cigarette smoking tobacco, replacement, therapy

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When is the best time to quit smoking?

Most of us are familiar with the statistic that in countries like the USA, UK, Canada and Australia (and many other developed countries) approximately 70% of current smokers say that they would like to quit smoking. An even greater proportion typically state that if they had their time again, they would choose never to start smoking.

However, if you ask them when they plan to quit, most give a time frame over 6 months in advance, but expect to have quit within 2 years. So we see a lack of urgency combined with an understanding that it would be a big mistake to let it drag on for much longer. The big problem, however, that the average smoker who stated 10 years ago, “I want to quit, but its not a good time right now, - I’ll definitely do it within the next 2 years” is still smoking today. What this means is that smokers tend to put off quitting for much longer than they plan to, and if they try to wait for “the right time” there is a very large chance that they end up waiting until the worst time – after the diagnosis of a serious illness caused by smoking.

A report by Professor Martin Jarvis and colleagues at University of London commented on the “delusion gap” between smokers’ expectations (53% expecting to be quit in 2 years) and reality (only 6% actually quitting in that time frame).

One of the reasons people often give for putting off a quit attempt is that they have too much stress in their life. Unfortunately, people who have stress now are fairly likely to continue having stress in the future. Cigarettes add to many of the most common stresses (financial problems, health problems etc) and the evidence is very clear that people who smoke are not less stressed than people who don’t. In fact, if you follow a group of smokers who successfully quit for 6 months the typical finding is that they report being less stressed as an ex-smoker than they did as a smoker. So stress is probably not a great reason for delaying quitting.

Another reason people sometimes have for delaying (often supported by psychologists like myself) is the belief that you need to do a lot of planning and preparation before trying to quit. Professor Robert West (University of London) recently published an interesting study that seemed to argue against that idea. Based on a survey of almost 2000 smokers and ex-smokers he found that almost half of the most recent quit attempts were made rather spontaneously (i.e. they made up their mind to try to quit on a day without prior planning on previous days), and perhaps more surprisingly, those who claimed to have made a quit attempt without any prior planning were twice as likely to still be quit at least 6 months later, compared with those planning ahead!

Now the tricky bit here is in interpreting what this means. No-one (or at least not the authors of the article, nor most of the commentators including myself) think this means that it is detrimental to plan your quit attempt. But what it does suggest that if you find yourself suddenly convinced by some thought, experience, or something you saw on TV, that now is the time to quit, then don’t talk yourself out of it by reasoning that you need to take time to plan. Go with the flow, get rid of your cigarettes and follow your instincts there and then.

So (perhaps predictably), the best answer to the question posed in the title is “right now”!


The paper by Professor Jarvis and colleagues can be found at: http://www.bmj.com/cgi/content/full/324/7337/608

The paper by Professor West and colleague can be found at:
http://www.bmj.com/cgi/content/full/332/7539/458

Labels: cessation, nicotine, nicotine addiction cigarette smoking tobacco, quit

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Is nicotine replacement therapy effective in the “real world”?

Over a hundred double-blind randomized placebo-controlled trials have evaluated the efficacy of nicotine replacement therapy for smoking cessation, and the results are very clear: use of NRT almost doubles the smokers’ chances of successfully quitting. Five years ago, a paper published in the Journal of the American Medical Association by Professor John Pierce and colleagues claimed that since becoming available over-the-counter, NRT was no longer effective. This study was based on retrospective recall of quit attempts by respondents to a large survey in California. Many researchers questioned the validity of the findings, partly based on evidence that smokers are more likely to forget unaided failed quit attempts, and partly because smokers who choose to use NRT tend to be more addicted than those choosing to quit on their own, and the Pierce study was not able to adequately measure this.

Since then, a number of studies have been published that shed more light on this issue. A more recent study by the same research group found that use of a pharmacological aid (NRT or bupropion) is more effective than no aid in households with either no other smokers or a smoke-free policy. This result was an interesting demonstration of the interaction between effects of a medication and the environment in which it is used. It also suggests that effectiveness of NRT has little to do with whether it is prescribed by a doctor or purchased over the counter. However, this study still relied on retrospective recall and so some doubts about recall accuracy remain.

Further light was shed on this issue in a study by Miller and colleagues published in the Lancet in 2005. They reported on a large scale distribution of free nicotine patches (via a telephone quitline) to over 34,000 people in New York City. Six months later they followed up a randomly selected sample of participants, and also a sample of people who called the quitline but did not receive patches due to mailing errors. They found that 33% of those receiving patches had quit 6 months later, as compared with only 6% among those not receiving them. This suggests that nicotine patches are effective when used along with very low intensity support.

Very recently, Professor Robert West and Xiaolei Zhou have reported in the journal, Thorax, the results of a multinational prospective study of over 3,605 smokers attempting to quit. This study found that those using NRT were about twice as likely (8% vs 4%) to remain continuously abstinent six months later. This study, like the New York City patch study, supports the findings from randomized clinical trials and demonstrates that smokers making a self-initiated quit attempt without additional behavioral support are twice as likely to remain abstinent for at least six months if they use NRT as compared with trying without NRT. Nicotine replacement therapy is therefore an effective aid to smoking cessation in the “real world”.

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Whats the problem with Accomplia/rimonabant (Zimulti) the weight-loss drug that also helps you quit smoking?

Rimonabant is the name of a drug that has been developed as an aid to weight loss in people who are obese. It is a novel cannabinoid receptor blocker – basically giving an effect a little bit like the opposite of the “munchies” reported by people after smoking cannabis. The drug was eagerly awaited in the United States, especially after publication of fairly impressive trial data on weight loss and lipid profile in three major medical journals and launches of the drug in Europe and South and Central America. There have also been numerous media reports that this “wonder drug” also helps people to quit smoking. Strangely, none of the trials of the drug for smoking cessation have been published, although some of the results have been presented at scientific meetings.

Then in early 2006, the FDA did not approve rimonabant. Instead, it issued an "approvable" letter to the parent company (Sanofi-Aventis) for weight loss, and a "non-approvable" letter for smoking cessation. Undisclosed requirements were apparently placed on Sanofi before final approval for the weight loss indication is granted. Until recently everyone was very tight lipped as to what the problem was. However, on June 13th an advisory committee met to review the data on rimonabant. While they accepted the fairly good data on weight loss, they were concerned about increased rates of psychiatric symptoms and voted 14-0 not to approve the drug until there is additional data on rimonabant’s safety profile. The 20mg dose (which is most effective for weight loss) was associated with approximately double the rate of psychiatric symptoms, including suicidality.

The full FDA briefing documents for that meeting are available online at: http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4306b1-00-index.htm . However, it now seems fairly clear that this drug will not be approved in the U.S. in the very near future, and its next chance will be on completion of another large trial that is currently underway for weight loss. The company is adding more detailed measurement of psychiatric symptoms into the ongoing trials and will be able report on these results in a couple of years. Of course, rimonabant is the first of this new class of drugs to reach the market (at least in other countries), and the evidence of its weight loss effects (and possible effects on smoking cessation) will encourage pharma companies to develop new medicines based on similar molecules and mechanisms of action. The first of these drugs to be found effective for both weight loss and smoking cessation, (without serious side-effects) will likely be a “blockbuster” drug. In the mean time it will be interesting to hear from colleagues in Europe and South America whether this drug appears successful for weight loss and/or smoking cessation, and whether those concerning side effects are a problem in those countries.

Labels: Accomplia, cessation, nicotine addiction cigarette smoking tobacco, rimonabant, weight

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Can quitting smoking trigger depression?

Adolescent smokers are more likely than non-smokers to subsequently develop depression, and adult smokers are more likely to have either current depression or a history of depression than adult non-smokers. So although some have suggested that tobacco may have some component that “medicates” depression, the evidence for this is not at all clear. But for the smoker who has previously suffered a major depressive episode it is reasonable to wonder whether stopping smoking might increase the risk of suffering another episode of depression.

Depression is one of the most common and most unpleasant of all illnesses. It is characterized by feeling consistently sad, hopeless and pessimistic for more than 2 weeks (usually much longer), and often involves sleep disturbance, fatigue and changes in appetite. Perhaps most importantly, major depression is a risk factor for both attempted and completed suicide. So anyone who has ever suffered from major depression may understandably be very reluctant to do anything that may increase the risk of feeling that bad again. Remembering that low/depressed mood (which is not the same as full blown depression) is one of the symptoms of nicotine withdrawal, one can understand why someone with a history of depression would become concerned when they experience the onset of depressive symptoms after quitting smoking. Some studies find that people with a history of depression have a lower quit rate when they try to quit smoking, compared to those without such a history. One reason for this may be that onset of depressive symptoms raises the concern that a major depressive episode may return and triggers a return to smoking. However, a critical question is whether such fears are justified. Can quitting smoking increase the risks of onset of major depression?

Professor John Hughes, of the University of Vermont recently reviewed all the published studies providing evidence relevant to this question. The rate of major depression in the year after successfully quitting varied considerably across studies, from as low as 1% to as high as 31%. There was fairly consistent evidence that people with a history of major depression were more likely to have another episode after quitting, but this is not surprising as people with a prior history of depression are more likely to have another episode regardless of whether they quit smoking or not. Two studies by Professor Stan Glassman at Columbia University found that depression occurred more frequently in people with a history of depression who succeeded in quitting smoking compared with those who continued to smoke. In his review, Professor Hughes commented that none of the studies provided conclusive evidence and that there was a high risk of “publication bias”. This refers to the tendency for studies that don’t find a difference/effect to be less likely to be published. So what can we conclude from all this?

It looks likely that having a history of major depression is associated with slightly greater difficulty quitting smoking, and an increased risk of recurrence of depression in the months/years after quitting smoking. It remains uncertain whether quitting smoking can actually trigger an occurrence of depression, although it is clear that the majority (69-99%) of people who quit (even those with a history of depression) do NOT experience major depression within a year of quitting.
But how might this affect the choice of treatment, particularly for those with a history of depression? If I had a close relative who wanted to quit smoking but had a history of major depression, my advice would be as follows:
1. To ensure that you get the best advice and support, attend a treatment center with staff who have been trained to provide tobacco treatment, including access to medical staff with experience providing the range of tobacco treatment medications.
2. To increase the chances of successfully quitting AND preventing unpleasant withdrawal symptoms make sure you use an adequate dose of medication approved for smoking cessation. For the heavy smoker that should involve discussing with the doctor the potential advantages of combination therapy, such as Zyban (bupropion), plus the nicotine patch, plus one of the acute dosing nicotine replacement therapies (nicotine gum, lozenge, inhaler or nasal spray).
3. Make use of all the counseling support services available – ideally combining attendance at regular group or individual appointments, plus registering with a smoking cessation website (e.g. www.quitnet.com ), plus use of a telephone quitline.
4. Don’t start reducing the prescribed medication until you are feeling very confident about maintaining abstinence from tobacco and have discussed it with your prescriber. As a rule of thumb, don’t consider reducing your prescribed smoking cessation medications until you have had fourteen consecutive days with no cravings, withdrawal symptoms or near lapses.
5. Stay engaged in counseling for at least a few months (and ideally longer) after you have come off your smoking cessation medications. This could be as simple as scheduled monthly appointments or telephone calls, but even this relatively infrequent contact during months 4-12 after quitting smoking will help maintain focus on abstinence and will enable the counselors to monitor symptoms and treat as required.

Now all of this may sound like a great deal more work than people typically plan on when they try to quit smoking. It is. But I would remind my relative that this is a difficult but life-saving behavior change they are about to embark on. One likely to add ten healthy years to their life. Its well worth the effort both to successfully quit and to look after ones mental health in the process.

Labels: bupropion, cessation, depression, nicotine addiction cigarette smoking tobacco

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Can Smoking Cessation Internet Sites Help You Quit?

Many smokers use the internet to seek help in stopping smoking. Thousands of websites (including this one) provide basic information and advice on stopping smoking, and over 30 focus on providing direct smoking cessation assistance (e.g. a tailored quit plan) rather than just information and advice. So do these smoking cessation websites actually help smokers to quit?

When one considers some of the advantages of the internet (easy access, anonymity, lack of face-to-face contact etc), one can immediately also see some of the challenges in evaluating smoking cessation websites. For example, how do you follow-up on people who visited a website anonymously, in order to find out if they quit smoking? Research on this topic has only recently started, but there are already some promising studies suggesting that some smoking cessation websites boost the smokers’ chances of quitting. A recent study by Dr Lynn Swartz at the Oregon Center for Applied Science compared one particular internet site with no intervention. They found that smokers given access to the smoking cessation internet site were roughly twice as likely to have quit smoking three months later. Another recent study by Dr Joanne Pike at University of Texas Health Science Center compared utilization and quit rates at 5 interactive websites and one static website, all of which aimed to help smokers quit. They found that some of the interactive websites had much higher participation rates than others, and that this was associated with the amount of interactivity available on the site. Sites containing a lot of interactive functions also tended to have more participants succeed in quitting smoking.

Many of the websites offer the chance to view some of the basic information pages immediately but require visitors to complete an online registration process (and possibly pay a fee) before being given full access to the more useful interactive features on the site. One of the top smoking cessation websites can be found at: www.quitnet.com . This site offers a range of interactive features including “chat rooms”, and “ask-the-expert” functions, as well as online “wizards” that automatically calculate how much money you have saved since you quit smoking. This site is widely used around the world, so that at any given moment there will be hundreds or thousands of people visiting the site for help to quit.

The advantages of these interactive smoking cessation websites are that they are available 24/7, from the comfort of your own home, are generally free or low cost, and can put you in touch with a whole community of people going through the same process. Website assistance can also be used in addition to other methods (e.g. counseling and/or medication). Generally the more help and support you can get, the more likely you are to succeed in quitting. If you found any websites particularly helpful (or unhelpful), let me know, so I can pass it on to others. Best of luck.

Labels: cessation, online, Smoking, website

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