Design and methodology of the first open-label trial of MDMA-assisted therapy for veterans with post-traumatic stress disorder and alcohol use disorder: Considerations for a randomized controlled trial.
Contemporary clinical trials communications October 1, 2024 Erica Eaton, Christy Capone, Brian J Gully et al. 2 citations
Posttraumatic stress disorder and alcohol use disorder frequently co-occur and lead to more severe symptoms, higher suicide risk, and poorer treatment outcomes. MDMA-assisted therapy shows promise; the FDA designated it a Breakthrough Therapy for PTSD based on six Phase 2 trials. This manuscript describes the design of the first open-label trial of MDMA-AT for military veterans with both PTSD and AUD, enrolling 12 participants. The study includes neuroimaging and biomarker measures to assess brain changes and neuroinflammation before and after treatment. The authors detail the complex clinical and regulatory processes involved in setting up the trial, aiming to establish standardized protocols and outcomes for future FDA approval.