This Phase II, randomised, open-label trial (n=52) will study the safety, tolerability and efficacy of MDMA-assisted therapy in adult veterans with post-traumatic stress disorder (PTSD). Participants will receive oral MDMA as part of therapy in either individual or group settings. The study is a single-centre, fixed-dose, parallel-group design with two experimental arms: individual therapy and group therapy. The MDMA regimen is 120 mg orally followed by a supplemental 60 mg dose, and the main outcomes are safety, tolerability and the Columbia Suicide Severity Rating Scale (C-SSRS) assessed over 15 months.
A Phase 2, single-center, fixed-dose, open-label study will explore the efficacy, safety, and tolerability of a 120 mg dose of oral MDMA followed by a supplemental dose of 60 mg MDMA in conjunction with therapy in individual versus group settings for adult veterans diagnosed with PTSD.