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

Sponsor
U.S. Army Medical Research and Development Command
Study ID
NCT07704762
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TREATMENT ARM: Full dose — DRUG
    Participants in this arm will receive full dose of MDMA integrated with Acceptance and Commitment Therapy (ACT)
  • CONTROL ARM: Active-controlled — DRUG
    Participants in this arm will receive lower dose of MDMA integrated with Acceptance and Commitment Therapy (ACT)

Study Details

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.

Key Dates

First listed
Jul 15, 2026
Start date
Oct 1, 2026
Status verified
Jul 2026
Primary completion
Jan 1, 2028
Completion
Oct 1, 2028

Study Design

Enrollment
86 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: CONTROL ARM: Active-controlled
    Low dose MDMA, 40mg
  • Experimental: TREATMENT ARM: Full dose
    Full dose MDMA, 60mg to 120mg (maximum)

Primary Outcome Measure

Change in Revised Clinician Administered PTSD Scale for DSM-5 (CAPS-5-R) Total Severity Score From Baseline to Primary Outcome [ Time Frame: The primary endpoint will be 14±3 weeks after the baseline independent rater CAPS-5-R visit and 1-9 days after the final Integration Session. ]

Central Contacts

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