In an important step toward medical approval, MDMA, the illegal drug popularly known as Ecstasy or Molly, was shown to bring relief to those suffering from severe post-traumatic stress disorder when paired with talk therapy.
Of the 90 people who took part in the new study, which is expected to be published later this month in Nature Medicine, those who received MDMA during therapy experienced a significantly greater reduction in the severity of their symptoms compared with those who received therapy and an inactive placebo. Two months after treatment, 67 percent of participants in the MDMA group no longer qualified for a diagnosis of PTSD, compared with 32 percent in the placebo group.
MDMA produced no serious adverse side effects. Some participants temporarily experienced mild symptoms like nausea and loss of appetite.
“This is about as excited as I can get about a clinical trial,” said Gul Dolen, a neuroscientist at Johns Hopkins University School of Medicine, who was not involved in the research. “There is nothing like this in clinical trial results for a neuropsychiatric disease.”
Before MDMA-assisted therapy can be approved for therapeutic use, the Food and Drug Administration needs a second positive Phase 3 trial, which is currently underway with 100 participants. Approval could come as early as 2023.
Mental health experts say that this research — the first Phase 3 trial conducted on psychedelic-assisted therapy — could pave the way for further studies on MDMA’s potential to help address other difficult-to-treat mental health conditions, including substance abuse, obsessive compulsive disorder, phobias, eating disorders, depression, end-of-life anxiety and social anxiety in autistic adults.
And, mental health researchers say, these studies could also encourage additional research on other banned psychedelics, including psilocybin, LSD and mescaline.
“This is a wonderful, fruitful time for discovery, because people are suddenly willing to consider these substances as therapeutics again, which hasn’t happened in 50 years,” said Jennifer Mitchell, a neuroscientist at the University of California, San Francisco, and lead author of the new study.
But some mental health experts urged restraint. Allen James Frances, a professor emeritus and the former chair of psychiatry at Duke University, who was not involved in the new study, warned that new treatments “are never as wonderful as first they seem.”
“All new treatments in medicine have always had a temporary halo effect by virtue of being new and by promising more than they can possibly deliver,” Dr. Frances said.
Unlike traditional pharmaceuticals, MDMA does not act as a band-aid that tries to blunt symptoms of PTSD. Instead, in people with PTSD, MDMA combined with therapy seems to allow the brain to process painful memories and heal itself, Dr. Mitchell said.
Critically, MDMA taken in isolation, without therapy, does not automatically produce a beneficial effect.
“It’s not the drug — it’s the therapy enhanced by the drug,” said Rick Doblin, senior author of the study and director of the Multidisciplinary Association for Psychedelic Studies, a nonprofit research group that sponsored and financed the clinical trials.
For this process to work, a person must be primed to engage with their trauma. Participants first undertook preparatory sessions with two trained therapists. Then in three sessions of eight-hours each, spaced a month apart, they received either an inactive placebo or MDMA. Neither the participants nor the therapists knew which. While most participants correctly guessed whether they received a placebo or MDMA, this did not undermine the study’s results or its methodology, which was agreed to in advance by the F.D.A.
Scott Ostrom, who participated in the study, had suffered from PTSD since returning home from his second deployment in Iraq in 2007. For more than a decade, he experienced debilitating nightmares. “Bullets would dribble out of the end of my gun, or I’d get separated from my team and be lost in a town where insurgents were watching me,” he said.