Clinical trial

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

U.S. Army Medical Research and Development CommandNot yet recruitingPhase 2Started Oct 1, 202686 enrolledNCT07704762

Abstract

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.

Topics & conditions

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MDMAPTSD

Keywords

Post-Traumatic Stress Disorder (PTSD)Acceptance and Commitment Therapy (ACT)Service MembersTraumaPsychotherapy ModalityPsychiatric Disorders3,4-MethylenedioxymethamphetamineActive DutyMDMA-Assisted TherapyPhase IIActive ControlledPsychedelic-Assisted TherapyPost Traumatic Stress Disorder PTSDPost Traumatic Stress Disorder

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