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

NCT07704762 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2026-07-15

No results posted yet for this study

Summary

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.

Conditions

  • PTSD
  • Post Traumatic Stress Disorder PTSD
  • Post Traumatic Stress Disorder

Interventions

DRUG

CONTROL ARM: Active-controlled

Participants in this arm will receive lower dose of MDMA integrated with Acceptance and Commitment Therapy (ACT)

DRUG

TREATMENT ARM: Full dose

Participants in this arm will receive full dose of MDMA integrated with Acceptance and Commitment Therapy (ACT)

Sponsors & Collaborators

  • Resilient Pharmaceuticals

    collaborator INDUSTRY

  • Walter Reed National Military Medical Center

    collaborator FED

  • Congressionally Directed Medical Research Programs

    collaborator FED

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • Shannon Ford, MD · WRNMMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2028-01-01
Completion
2028-10-01
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07704762 on ClinicalTrials.gov