MDMA-Assisted Group Therapy for PTSD: Development of a Novel Protocol

Abstract

• This paper describes a novel protocol for group-based MDMA-assisted therapy for veterans with PTSD. • This single-arm, open-label study will focus on feasibility, safety, and preliminary effectiveness. • This study will inform randomized controlled trials of MDMA-assisted group therapy for PTSD. • Information gained from this pilot trial may inform post-approval clinical implementation. • Results may contribute to more rapid dissemination and accessibility compared to individual treatment. Posttraumatic stress disorder (PTSD) presents unique psychosocial challenges among veterans. Group therapy is used widely in the Veterans Health Administration to treat PTSD, yet further research is needed to optimize group interventions. The integration of group therapy with 3,4-methylenedioxymethamphetamine (MDMA) represents a promising strategy for PTSD recovery given potential synergy between the therapeutic effects of group cohesion and the prosocial effects of MDMA. This paper describes the development of a clinical research protocol for a single-arm, open-label study assessing the feasibility, safety, and preliminary effectiveness of MDMA-assisted group therapy in a sample of Veterans diagnosed with PTSD within the veterans Affairs Portland Healthcare System. Enrolled veterans will be assigned to one of 3 cohorts of 4–6 participants each (up to N = 18). In addition to individual and group preparation and integration, this novel protocol includes both individual and group MDMA sessions. PTSD symptom severity will be measured by blinded raters using the Clinician-Administered PTSD Scale for DSM-5 at baseline and at 1-month follow-up. As the first clinical trial combining group therapy with MDMA-assisted therapy for PTSD, this study will provide valuable data on feasibility, the unique risks and benefits of this model, and preliminary effect sizes for the development of larger randomized controlled trials.