Prior Positive Results Confirmed in MAPS-Sponsored, Philanthropy-Funded Phase 3 Trial
- MAPP2, the second Phase 3 trial of MDMA-assisted therapy, treated 104 participants living with PTSD with either MDMA-assisted therapy or placebo with therapy
- The results confirmed findings from MAPP1; no serious adverse events were observed among the participants
- In a first for psychedelic-assisted therapy trials, more than half of MAPP2 participants identify as people of color
The nonprofit Multidisciplinary Association for Psychedelic Studies’ (MAPS) clinical research program has achieved an important milestone: a successful confirmatory Phase 3 trial of MDMA-assisted therapy for posttraumatic stress disorder (PTSD). The clinical research program that began in 1992 has been sponsored by the nonprofit MAPS and funded through philanthropic donations. Since 2014, MAPS Public Benefit Corporation (MAPS PBC), a wholly-owned subsidiary of MAPS, has administered the trials.
When I first articulated a plan to legitimize a psychedelic-assisted therapy through FDA approval, many people said it was impossible. Thirty-seven years later, we are on the precipice of bringing a novel therapy to the millions of Americans living with PTSD who haven’t found relief through current treatments. The impossible became possible through the bravery of clinical trial participants, the compassion of mental health practitioners, and the generosity of thousands of donors. Today, we can imagine that MDMA-assisted therapy for PTSD may soon be available and accessible to all who could benefit.Rick Doblin, Ph.D., Founder and Executive Director of MAPS
We have initial results from MAPP2, our second, confirmatory Phase 3 clinical trial of MDMA-assisted therapy for PTSD, and we’re celebrating. The results from MAPP2 were statistically significant, similar to our pivotal study MAPP1, with no new safety signals of concern.
