Clinical Trial of MDMA-Assisted Therapy for Military Service Members With Posttraumatic Stress Di… (NCT07704762) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Clinical Trial of MDMA-Assisted Therapy for Military Service Members With Posttraumatic Stress Disorder
86 participantsStarted 2026-10-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Positive endorsement of at least 1 index trauma on the LEC-5.
. Have a PCL-5 total score of 38 or greater at screening.
. Meet DSM-5-TR criteria for current PTSD per Mini International Neuropsychiatric Interview (MINI) at screening with a symptom duration of 6 months or longer.
. Meet criteria for PTSD diagnosis per CAPS-5-R with a score of 26 or greater.
. Are at least 18 years old at the time of enrollment.
. Weigh greater than 48 kilograms.
. Are able to swallow pills.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Revised Clinician Administered PTSD Scale for DSM-5 (CAPS-5-R) Total Severity Score From Baseline to Primary Outcome
Timeframe: 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.
Trial details
NCT IDNCT07704762
SponsorU.S. Army Medical Research and Development Command
. Are fluent in speaking, reading, and comprehending English.
Exclusion criteria
. History of or current primary psychotic disorder to include Schizophrenia, Schizoaffective Disorder, or Bipolar Disorder 1 assessed via MINI or clinical evaluation.
. Current Major Depressive Disorder with Psychotic Features assessed via MINI or clinical evaluation.
. Current eating disorder with active purging assessed via MINI or clinical evaluation.
. Current Borderline Personality Disorder assessed via SCID-5-PD or clinical evaluation.
. Any of the following findings on Screening C-SSRS:
. Suicidal ideation score of 5 within the last month
. Suicidal ideation score of 4 or greater in the last month at a frequency of once per week or more
. Any suicidal behaviors within the last 3 months. The exception is that non suicidal self-injurious behavior is not exclusionary if approved by the PI.