Clinical Trial 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.

NCT Number	NCT07704762
Lead Sponsor	U.S. Army Medical Research and Development Command Collaborators: Resilient Pharmaceuticals, Walter Reed National Military Medical Center, Congressionally Directed Medical Research Programs
Conditions	PTSD, Post Traumatic Stress Disorder PTSD, Post Traumatic Stress Disorder
Enrollment	86 participants
Start Date	2026-10-01
Primary Completion	2028-01-01 (estimated)
Study Completion	2028-10-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-15