This randomized, interventional trial (n=30) will compare MDMA-assisted Cognitive Processing Therapy (three MDMA sessions plus preparatory and integration therapy) versus standard Cognitive Processing Therapy for Veterans with severe PTSD.
Randomized, parallel-group trial comparing MDMA-assisted Cognitive Processing Therapy (MDMA-aCPT) with standard Cognitive Processing Therapy (CPT) in U.S. military Veterans with severe PTSD to assess clinical effectiveness, implementation feasibility, and health economics.
MDMA-aCPT includes one 90-minute preparatory session, three ~8-hour experimental MDMA sessions (initial doses 80 mg with optional supplemental doses; later sessions 80 or 120 mg with optional supplements), and three 90-minute integration sessions, alongside 8–15 CPT sessions (average 12).
Outcomes include PTSD symptom reduction, feasibility and implementation metrics within the VA system, and economic assessments to inform potential deployment of MDMA-aCPT in VA settings.
MDMA-assisted Cognitive Processing Therapy: CPT plus three MDMA experimental sessions with preparatory and integration sessions.
Session 1: 80 mg with optional 40 mg supplement 1.5–2 h later. Sessions 2–3: 80 or 120 mg initial dose with optional 40 or 60 mg supplement.
Cognitive Processing Therapy alone (8–15 sessions, avg 12).
8–15 CPT sessions (average 12), ~1–1.5 hours each; optional crossover to MDMA-aCPT after 6 months.