The nonprofit Multidisciplinary Association for Psychedelic Studies’ (MAPS) has announced its clinical research programme has had a successful confirmatory Phase 3 trial of MDMA-assisted therapy for post-traumatic stress disorder (PTSD).
MAPS’ second Phase 3 trial of MDMA-assisted therapy – MAPP2 – treated 104 participants living with PTSD with either MDMA-assisted therapy or placebo with therapy.
The organisation has stated that the results confirmed findings from MAPP1; in that, no serious adverse events were observed among the participants.
Rick Doblin, Ph.D., Founder and Executive Director of MAPS stated: “When I first articulated a plan to legitimise 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.”
The full data from MAPP2, expected to be published in a peer-reviewed journal later this year, will support MAPS PBC’s new drug application to be filed with the U.S. Food and Drug Administration (FDA).
MAPP1 and MAPP2, the only completed Phase 3 trials of a psychedelic-assisted therapy, were conducted at 15 sites in the US, Canada, and Isreal.
Today, Phase 2 trials are being planned or conducted evaluating MDMA-assisted therapies for conditions closely related to PTSD, such as substance use disorder and eating disorders. Trials of other therapies in combination with MDMA are being planned or conducted, such as couples therapy and group therapy among Veterans.
These additional Phase 2 trials will determine if MDMA-assisted therapies may be effective for other conditions or with other treatment modalities commonly used to address PTSD.
MAPS has also confirmed that, In a first for psychedelic-assisted therapy trials, more than half of MAPP2 participants identify as people of colour.
