HomeScienceMDMA Therapy for PTSD Inches Closer to U.S. Approval

MDMA Therapy for PTSD Inches Closer to U.S. Approval

HTML tags retained: MDMA-assisted therapy seems to be effective in reducing symptoms of post-traumatic stress disorder, according to a study published on Thursday.The research is the final trial conducted by MAPS Public Benefit Corporation, a company that is developing prescription psychedelics. It plans to submit the results to the Food and Drug Administration as part of an application for approval to market MDMA, the psychedelic drug, as a treatment for PTSD, when paired with talk therapy.If approved, “MDMA-assisted therapy would be the first novel treatment for PTSD in over two decades,” said Berra Yazar-Klosinski, the senior author of the study, which was published in Nature Medicine, and the chief scientific officer at the company. “PTSD patients can feel some hope.”PTSD affects about 5 percent of the adult population of the United States each year. But conventional therapies and medications only help, at best, around 50 percent of patients, said Dr. Stephen Xenakis, a psychiatrist and the executive director of the American Psychedelic Practitioners Association, who was not involved in the study.”My clinical experience is that too many men and women have lost hope with conventional treatments and therapies and feel the only ‘out’ for them is committing suicide,” Dr. Xenakis said. “We need to do something more to help them, and MDMA-assisted therapy offers a new, potentially lifesaving option when done thoughtfully and professionally.”MDMA, also known as Ecstasy or Molly, has been an illegal substance since 1985, when the Drug Enforcement Administration classified it as a Schedule 1 drug, placing it in the highest category for controlled drugs that the agency deems of no medical use and that have a high potential for abuse.Before that, MDMA was administered by an estimated hundreds of therapists in North America and Europe for couples counseling, personal growth and to address trauma.”The big tragedy to point out is that it was pretty clear in the late 1970s and early 1980s that MDMA had incredible therapeutic potential,” said Rick Doblin, founder of the Multidisciplinary Association for Psychedelic Studies (MAPS), a nonprofit group that owns MAPS PBC. “All the suffering since then, because MDMA was criminalized, is enormous.”MAPS has been advocating the legalization of MDMA-assisted therapy since 1986, and supporting research of its use in treating PTSD since 2001. The Heffter Research Institute, another nonprofit group, has been doing the same for psilocybin, the active ingredient in magic mushrooms, since 1993.The F.D.A. in 2017 granted “breakthrough therapy” status to MDMA-assisted therapy as a treatment for PTSD. The designation allows the development of promising experimental drugs to be fast-tracked. Psilocybin-assisted therapy for treatment-resistant depression was granted breakthrough status in 2018.The 104 participants in the new study had been diagnosed with moderate to severe PTSD and had lived with the condition for an average of 16 years. They included victims of childhood trauma, combat veterans, survivors of sexual assault and others. Many had a history of suicidal thoughts and also suffered from comorbidities such as depression and alcohol use disorder.Each participant worked with a two-person therapy team and received three 90-minute preparatory, talk therapy sessions followed by three treatment cycles, spaced one month apart. Each consisted of an eight-hour experimental session in which the participant took either MDMA or a placebo paired with talk therapy, and then attended three 90-minute talk therapy sessions.During the experimental sessions, 53 participants were given MDMA and 51 were given an inactive placebo. Neither the therapists nor the participants were informed which patients had received the MDMA.The participants in the group that were given MDMA experienced significantly greater reductions in their PTSD symptoms compared with those in the group that were given a placebo, according to the research article.