The FDA approves a clinical trial for ecstasy to treat PTSD, but one expert tells Healthline caution should be used in this experiment.
The psychoactive drug MDMA, better known as ecstasy, has cleared yet another hurdle on its way to possible approval as a treatment for post-traumatic stress disorder (PTSD).
However, experts say there’s reason for caution.
In late August, the Food and Drug Administration reportedly granted MDMA “breakthrough therapy” status as a treatment for PTSD.
That helps clear the way for phase III clinical trials, which were first announced last fall.
Funding the research is the Multidisciplinary Association for Psychedelic Studies (MAPS), a nonprofit organization that supports the legalization of certain drugs, including MDMA, for medical use.
A series of phase II clinical trials, treating a total of 130 people with PTSD, showed enough promise for the FDA to greenlight the phase III trials.
Treatment consisted of giving patients the drug once per month in conjunction with psychotherapy sessions.
The upcoming phase III trials will serve as the last stage of testing before the FDA assesses whether the drug should be approved as a prescription treatment.
Currently, PTSD is often treated by counselling or psychotherapy.
Dr. John Krystal, director of the clinical neurosciences division at the Department of Veterans Affairs (VA) National Center for PTSD, outlined these methods in an email to Healthline.
“The Department of Veterans Affairs has rolled out two forms of psychotherapy for PTSD that are supported by a compelling body of evidence supporting their effectiveness and tolerability: Progressive Exposure Therapy or Cognitive Processing Therapy,” he wrote. “By ‘rolled out,’ I mean that a tremendous effort has been made on a national basis to train therapists in the VA to deliver these treatments in ways that have been demonstrated to be effective for many patients.”
Doctors may prescribe medication to PTSD patients who don’t respond adequately to psychotherapy, but there are downsides.
Only two drugs — sertraline (Zoloft) and paroxetine (Paxil) — are currently approved by the FDA for the treatment of PTSD.
Krystal says that while these drugs help many people with PTSD, others do not respond adequately.
“This is a significant problem because there has not been a new FDA-approved treatment for PTSD in 15 years,” Krystal wrote. “Since no other medications are approved by the FDA for the treatment of PTSD, physicians typically prescribe other medications to treat PTSD. These other medications may or may not have much evidence to support their effectiveness and safety for people with PTSD symptoms. Even when treated with multiple medications and current psychotherapies, some patients will continue to suffer with severe and disabling PTSD symptoms. Thus, there is an urgent need for new medication treatments for PTSD.”
Psychoactive drugs have long been proposed as a treatment for various disorders.
LSD was initially introduced in the 1940s as a treatment for psychiatric issues.
More recently, researchers noted that psilocybin — the active compound in “magic mushrooms” — may help reduce anxiety and depression in cancer patients.
The recent MDMA trials come after years of research into the effects of the drug on people with PTSD. A 2012 study showed that people with PTSD reported a 56 percent decrease in the severity of symptoms after three doses.
Krystal says that MDMA stimulates the release of serotonin and creates feelings of positivity and openness. That’s what makes it a popular party drug.
“At raves, these distortions may create situations where people intoxicated on MDMA might be exploited by other people,” he writes. “However, it is possible that in the therapeutic setting, that this openness can be exploited to help people with PTSD who struggle to trust other people and who are socially isolated. There is some very preliminary evidence that MDMA administration may enhance some forms of psychotherapy for PTSD.”
Krystal cites several key hurdles that will need to be overcome before MDMA can be viewed as an established PTSD treatment.
First, he says, experts will need clear and convincing evidence that MDMA is an effective PTSD treatment — something that the upcoming phase III trials should shed some light on.
He also notes that clinical trials will need to establish that MDMA will not worsen PTSD or PTSD-related problems.
Finally, says Krystal, there’s a high potential of abuse, considering MDMA is widely known as a party drug.
“The combination of PTSD and chronic pain may increase the risk for dependence on medically-prescribed opiates,” he writes. “There are concerns that people with PTSD might be more likely to abuse MDMA.”
While questions remain, phase III trials should establish whether or not MDMA is a viable treatment for PTSD, a widespread disorder that’s often difficult to treat.
“I am very concerned about the risks associated with MDMA administration,” writes Krystal. “However, I am also extremely concerned about the risks associated with ineffectively treated PTSD. In my view, the need for more effective PTSD treatments justified carefully designed clinical trials that include protections for participants against the risks outlined above. We can then determine whether MDMA is a safe and effective treatment for PTSD based on the data that is generated.”
This story was originally posted on Dec. 2, 2016 and was updated on August 31, 2017.