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.

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.
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About the Author

MA, MAppSci, PhD

Dr. Jonathan Foulds is an expert in the field of tobacco addiction.