Report: MDMA-Assisted Therapy for PTSD Clears Major Hurdle

Research expected to be published later this month demonstrated that MDMA brought relief to individuals suffering from post-traumatic stress disorder—a key step to MDMA-assisted therapy receiving FDA approval for the treatment of PTSD—according to a report published Monday by the New York Times.

The findings will be published in an upcoming edition of the journal Nature Medicine.

“There are occasional seismic events that occur in psychiatry. The study of MDMA-assisted psychotherapy for PTSD certainly is one such iconic moment,” says Rakesh Jain, MD, MPH, a clinical professor in the Department of Psychiatry at the Texas Tech Health Sciences Center School of Medicine and Sana Symposium steering committee member. “These study results and the eventual FDA approval will profoundly change the future of psychiatry and mental health.”

The study included 90 patients with PTSD, divided into two groups: those who received MDMA during therapy and those who received an inactive placebo. All participants engaged in preparatory sessions with two therapists. Then, they participated in 3 sessions, spaced a month apart, that each lasted 8 hours. In those sessions, patients received either MDMA or the placebo.

Of those who received MDMA, 67% no longer qualified for a PTSD diagnosis after two months vs. 32% of those in the placebo group. No serious side effects were reported.

Rick Doblin, the study’s senior author who is also executive director of the Multidisciplinary Association for Psychedelic Studies (MAPS) and a member of the Sana Symposium steering committee, pointed out that MDMA taken in isolation does not necessarily produce the same effect as what was observed in the trial.

“It’s not the drug—it’s the therapy enhanced by the drug,” Doblin told the Times.

Another Phase 3 trial—currently underway with 100 participants—must be completed before MDMA-assisted therapy can receive FDA approval. That milestone could be reached by 2023, the Times reported.