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Clinical Trial of MDMA-Assisted Therapy for Military Service Members With Posttraumatic Stress Disorder

StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
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
(from sponsor)		 PTSD, Post Traumatic Stress Disorder PTSD, Post Traumatic Stress Disorder
Related terms Combat Disorders, Mental Disorders, Stress Disorders, Post-Traumatic, Wounds and Injuries
Enrollment 86 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov