Post-traumatic stress disorder (PTSD) presents a major public health problem for which currently available treatments are modestly effective. We report the findings of a randomized, double-blind, placebo-controlled, multi-site phase 3 clinical trial (NCT03537014) to test the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of patients with severe PTSD, including those with common comorbidities such as dissociation, depression, a history of alcohol and substance use disorders, and childhood trauma.
A long-awaited study is making worldwide headlines for finding that the outlawed psychoactive drug MDMA is startlingly effective in treating post-traumatic stress disorder (PTSD). But researchers and study participants say the substance itself, while extremely powerful, catalyzes healing rather than working on its own: MDMA treatment also requires dozens of hours of therapy—before, during and after the drug experience—with professionals whose special training is expensive and intense.
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.