10/14/2023 0 Comments Finale trial version 2017![]() On August 16, 2017, the FDA granted Breakthrough Therapy Designation to MDMA for the treatment of PTSD. Food and Drug Administration (FDA) before deciding whether to approve MDMA as a legal prescription treatment for PTSD, required to be used in conjunction with therapy in an outpatient setting with a residential stay. The trials build on the promising results of MAPS’ completed Phase 2 clinical trials, and are the final phase of research required by the U.S. Studies MAPP1 and MAPP2 are randomized, double-blind, placebo-controlled, multi-site clinical trials that assess the safety and efficacy of MDMA-assisted therapy in 200-300 participants with severe posttraumatic stress disorder (PTSD) from any cause, aged 18 and older. An overview of the MAPS study, study sites, prior results, and ways to get involved with participating in existing studies and getting trained through the MAPS MDMA Therapist Program Phase 3 MDMA PTSD Summary
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