An Open-Label Feasibility and Safety Study of MDMA-Assisted Group Therapy for the Treatment of Posttraumatic Stress Disorder in Veterans
The current FDA-guided protocol for individual patient MDMA-assisted therapy for PTSD requires numerous two-therapist sessions for each individual patient and could be challenging for accessibility for marginalized populations. A group therapy protocol, in which most of the therapy sessions are conducted in a group setting, would significantly decrease both the time and cost associated with treatment, further supporting accessibility and rapid post-approval dissemination. This study will explore the risk:benefit ratio of group therapy as compared to the individual therapy of MDMA-assisted therapy for PTSD.
This Phase 2, open-label, non-randomized, three cohort study will assess the feasibility and safety of MDMA-assisted group therapy for the treatment of PTSD in veterans. The study will be conducted in up to N=18 participants, recruited in three cohorts of six participants and receive therapy sessions throughout their participation in these groups.