Multidisciplinary Association for Psychedelic Studies (“MAPS”), a non-profit research, advocacy, and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and empathogens, has recently announced the expansion of their Food and Drug Administration (“FDA”) regulated MDMA clinical trials. The study, which has been conducted at 15 locations in the U.S., Canada, and Israel, hopes to clarify MDMA’s potential medicinal benefits in the treatment of post-traumatic stress disorder (“PTSD”). Now, eight study sites are actively seeking trial participants in California, Colorado, Louisiana, and New York to further the study’s third phase.
The goal in researching MDMA as PTSD treatment is, as MAPS states, “to find a method to heal the psychological and emotional damage caused by sexual assault, war, violent crime, and other traumas.”1
As a part of study volunteers are either given MDMA or a placebo and must attend psychotherapy sessions at a MAPS research facility. Over the course of 12 weeks, the participants will complete twelve preparation and integration sessions without the drug. MDMA or a placebo will then be administered to participants undergoing psychotherapy in three separate day-long research sections scheduled roughly a month apart.
One of the only organizations in the U.S. currently studying potential educational and medicinal benefits of MDMA, MAPS has spent an estimated $26.9 million in their plan towards FDA approval.
Phase 3 trials are set to be the final stages of the study specifically designed to assess, “the efficacy and safety of MDMA-assisted psychotherapy in adult participants with severe PTSD.”2 The data obtained from MAPS’ research will be analyzed by the FDA to better inform their decision to potentially approve MDMA as legal PTSD treatment. Should MDMA receive FDA approval, it would be available in an outpatient setting, albeit paired with psychotherapy sessions.
MAPS has previously sponsored studies for MDMA-assisted psychotherapy for autistic adults suffering from social anxiety, as well as anxiety related to severe illness. The current PTSD-focused study is a part of MAPS’ plan to advocate for MDMA to be FDA recognized as approved prescription medicine by 2021.
- The Multidisciplinary Association for Psychedelic Studies. “MDMA-Assisted Psychotherapy.” MAPS. Accessed January 31, 2019. https://maps.org/research/mdma.
- The Multidisciplinary Association for Psychedelic Studies. “Phase 3 Trials of MDMA-Assisted Psychotherapy for PTSD: 8 Sites Screening Participants.” MAPS. Accessed January 31, 2019. https://maps.org/research/mdma/ptsd/phase3/timeline/7602-phase-3-trials-of-mdma-assisted-psychotherapy-for-ptsd-8-sites-screening-participants?pk_campaign=2019-01-Newsletter-January-Email&pk_kwd=toc-phase3.