MDMA-Assisted Psychotherapy in Veterans With Combat-Related, Refractory PTSD
Single-site, open-label Phase II study testing feasibility of MDMA given with manualized psychotherapy for combat-related, treatment-resistant PTSD in US veterans (first 10 eligible to receive medication; up to 50 consented).
Details
Open-label, single-site Phase II study in VA-enrolled combat veterans with treatment-resistant PTSD. Up to 50 veterans may be consented; the first 10 who meet criteria will be eligible to receive study medication.
Intervention consists of three single-dose experimental MDMA-assisted psychotherapy sessions (Session 1: 80 mg initial ±40 mg supplemental; Sessions 2–3: 120 mg initial ±40 mg supplemental) with three preparatory psychotherapy sessions and nine integrative follow-up sessions; primary endpoint assessed ~2 months after the third experimental session and long-term follow-up at 12 months.
Primary outcome: CAPS-5 change from baseline to primary endpoint. Secondary measures include PCL-5, BDI-II, AUDIT-C, DUDIT, PSQI, PTGI, healthcare utilisation, and suicidality (C-SSRS). Safety procedures include overnight hospital observation after sessions and medication tapering prior to dosing when required.