MDMA-Assisted Therapy For PTSD Edges Closer To FDA Approval After Largest-Ever Trial

If recently initiated phase 3 trials go as well as past completed studies, including this one, MDMA-assisted psychotherapy could be approved by the FDA in 2021. Cultura Motion/Shutterstock

Exciting results from the largest-ever trial assessing MDMA-assisted psychotherapy for the treatment of post-traumatic stress disorder (PTSD) have provided even more evidence that the highly regulated party drug – also known as ecstasy or "molly" – has the potential to revolutionize mental health interventions.

The phase 2 investigation, now published in the Journal of Psychopharmacology, is the latest in a spate of promising MDMA for PTSD studies sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS), a non-profit organization dedicated to advancing the use of psychedelic compounds for improving human health and well-being through research, education, and advocacy. Based on the high success rate and low risk seen thus far, phase 3 MDMA trials were initiated in September 2018.

The FDA-sanctioned assessment included 28 adults with PTSD who did not respond to at least one pharmacotherapy and/or psychotherapy regimen. After three 90-minute preparatory sessions with trial therapists grouped into eight different teams, each participant was randomized to take either a high active dose of 100 or 125 mg MDMA or a low, 40-mg dose at the beginning of two eight-hour psychotherapy sessions spaced one month apart. Neither the participant nor the therapists present were aware of what dose was administered. Using a similar set-up as the pioneering psilocybin- and LSD-assisted psychotherapy experiments of the 1950s-1970s, the sessions were unstructured and experience-based, rather than discussion-based.

“Therapists presented neither agendas nor solutions, and remained curious, open, and attentive to the participant’s developing experience. As much as possible, they followed the participant’s process and respected their pace, creating a sense of safety and communicating trust in the participant’s innate capacity for healing,” the authors wrote. (If you want to know more about this emerging form of therapy, we recommend reading this incredible new book).

At a check-in appointment one month after the second session, 42.9 percent of those given the active dose no longer qualified for a diagnosis of PTSD, compared to 33.3 percent in the low-dose MDMA group. At this point in the study, the study’s "blinding" was broken, and participants and their therapy teams were informed of the doses they had been assigned. Moving forward, the subjects who had been given low doses completed three active-dose MDMA sessions, each one month apart, while those who had already done two active dose sessions completed one more 100 mg to 125 mg MDMA-assisted session.

One year after their third active dose session, a whopping 76 percent of participants no longer met the diagnostic criteria for PTSD – a remarkable finding that tidily demonstrates how efficient and long-lasting MDMA’s psychotherapeutic effects appear to be.

"[T]he results of the study indicate that this treatment has the potential to greatly improve the lives of people suffering from PTSD, regardless of the source of their trauma,” principal investigator Marcela Ot’alora said in a statement. “After treatment, a great majority of our participants have reported feeling more connected to themselves and to others, more joy, more compassion, and with new skills for facing life’s challenges.”

Last summer, the FDA granted "breakthrough therapy" designation to MDMA-assisted psychotherapy for PTSD, meaning that the approval review process will be expedited based on evidence that the treatment offers significant benefits over the currently available options. Breakthrough designations are only given to treatments for serious or life-threatening conditions.

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