Multidisciplinary Association For Psychedelic Studies (MAPS)

Results: MAPS announced the publication of the long-term follow-up results of six Phase 2 clinical trials of MDMA-assisted therapy for the treatment of posttraumatic stress disorder (PTSD) in the peer-reviewed journal Psychopharmacology. The paper is the most comprehensive analysis yet published of the safety and durability of treatment outcomes following MDMA-assisted therapy for PTSD. The results show that for a majority of participants, the benefits of MDMA-assisted therapy for PTSD extended at least 12 months after the treatment sessions. Sponsored by MAPS, the controlled, randomized, double-blind trials found that, two months following their last session, 56% of 100 participants no longer met diagnostic criteria for PTSD. In the newly published analysis, 91 participants were interviewed at least 12 months later. Of these participants, 67% did not qualify for a PTSD diagnosis. One of the studies included data from an average of 3.8 years after treatment. “Trauma exposure has emerged as one of the most pressing public health issues of our time and is now at the forefront of global consciousness due to the COVID-19 pandemic and rising visibility of systemic oppression,” said Berra Yazar-Klosinski, Ph.D., paper co-author and Deputy Director and Head of Research Development and Regulatory Affairs at MAPS. “Although our Phase 3 trials are not yet completed, these long-term data support the hypothesis that MDMA-assisted therapy may provide significant advantages in treatment outcomes, safety, and durability over available PTSD treatments. This is the breakthrough that the world needs right now.” The trials were conducted by independent investigators in South Carolina (two trials), Colorado, Canada, Switzerland, and Israel. Trial participants included women and men with chronic, treatment-resistant PTSD from a wide variety of causes. PTSD symptoms were assessed using the Clinician-Administered PTSD Scale (CAPS-IV) at baseline, one to two months after their last MDMA-assisted therapy session, and at least 12 months after their final session. The course of double-blind treatment included one to three eight-hour MDMA-assisted therapy sessions spaced three to five weeks apart, combined with weekly non-drug therapy sessions. Outcomes were assessed by blinded Independent Raters. Based on these results, in August 2017, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to MDMA-assisted therapy for PTSD, acknowledging that it “may demonstrate substantial improvement over existing therapies” and agreeing to expedite its development and review. The FDA also considered MAPS’ prior published Phase 2 results when it agreed to MAPS’ Expanded Access program in January 2020. The research also received major confirmation when it passed its crucial interim analysis in May 2020.

Target demographics: Any person whose life may be aided by the transformative nature of psychedelic therapy

Geographic areas served: Worldwide

Programs: Phase 3 trials of MDMA-assisted therapy; Psychedelic peer support at events around the world; Education about the benefits and risks of psychedelic medicine