Group MDMA-therapy for Veterans With PTSD (Group-MVP)
This open-label, non-randomized Phase IIa trial (n=18) evaluates the feasibility and safety of MDMA-assisted group therapy for treating PTSD in veterans. Conducted by the Portland VA Research Foundation, the study employs a unique treatment package comprising two once-monthly open-label MDMA sessions combined with non-drug preparatory and integrative therapy, both individual and group-based.
Details
This Phase 2a, open-label, non-randomized, three-cohort study assesses feasibility and safety of MDMA-assisted group therapy for veterans with at least moderate PTSD; up to 18 participants are recruited in three cohorts of six.
Treatment comprises four preparatory sessions, two once-monthly MDMA sessions (120 mg with optional 60 mg supplemental at 1.5–2 hours), and integrative individual and group therapy; primary outcome is CAPS-5 assessed by a blinded independent rater pool.