A Randomized, Double-Blind, Active-Controlled, Clinical Trial of the Safety, Efficacy, and Durability of MDMA-Assisted Therapy for Military Service Members With Posttraumatic Stress Disorder
This study is a Phase 2, randomized, double-blind, active-controlled, two-arm, single-site clinical trial designed to evaluate the safety, tolerability, and feasibility of MDMA-Assisted Therapy (MDMA-AT) for Service Members (Active Duty, Guard, or Reserve) diagnosed with moderate-to-severe Post-Traumatic Stress Disorder (PTSD) within a Military Health System (MHS) setting. The trial incorporates Acceptance and Commitment Therapy (ACT) as a core therapeutic modality. Participants will receive MDMA-AT utilizing either full-dose or active-control low-dose MDMA. The trial will also assess a regional referral center model by recruiting participants locally from the National Capital Region and non-locally across the MHS.
- Status
- planned
- Phase
- Phase 2
- Institution
- U.S. Army Medical Research and Development Command
- Principal investigator
- Shannon Ford, MD
- Start date
- 2026-10-01
- End date
- 2028-10-01
- Registry ID
- NCT07704762
Tracked by the DMT Code Clinical Trials Observatory, an open record of DMT-related clinical research.