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MDMA-Assisted Therapy for Veterans With PTSD and Alcohol Use Disorder

{ "MDMA-Assisted Therapy for Veterans With PTSD and Alcohol Use Disorder", "This study is testing a new way to treat Post-Traumatic Stress Disorder (PTSD) and Alcohol Use Disorder (AUD) in military Veterans. It combines therapy with either a full dose of midomafetamine hydrochloride salt (MDMA HCl) or a lower, “active placebo” dose of MDMA HCl. Researchers want to see if MDMA-assisted therapy is safe and effective in reducing symptoms of PTSD. The study plans to enroll 80 participants. To join, you must be at least 18 years old and currently receiving care from the VA. The main way they will measure success is by looking at changes in your PTSD symptoms using a special rating scale (CAPS-5) over about 16 weeks. The current status of this study is unclear.", "design": "This is a randomized controlled trial, meaning participants will be randomly assigned to receive either the full dose of MDMA or the active placebo dose. The study plans to enroll 80 participants.", "commitments": "Participants will have three once-monthly experimental therapy sessions with MDMA, along with non-drug preparatory and integrative therapy. You will also complete assessments at the start, after treatment, and at 3- and 6-month follow-ups.", "compensation": "Not stated in the trial record.", "follow_up": "Participants will be followed up at 3 and 6 months after treatment.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07118839

MDMA-Assisted Therapy for Veterans With PTSD and Alcohol Use Disorder

Recruiting
PHASE2Ages 18+InterventionalTreatment
VA Office of Research and Development
~80 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:Full Dose MDMAMDMA-Assisted psychotherapyActive Placebo Dose MDMA

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score
Measured over from Baseline (Visit 3) to Visit 16 (approximately 16 weeks post-baseline)

Conditions

Post Traumatic Stress Disorder
Alcohol Use Disorder

Explore related trials

Alcohol use disorderPost-Traumatic Stress Disorder

Where it's being run

2 sites across 2 states
Connecticut1
Rhode Island1

Study leadership

  • Erica M. Eaton, PhD · PRINCIPAL_INVESTIGATOR · Providence VA Medical Center, Providence, RI

Who to contact

Erica M Eaton, PhD
[email protected]
(401) 273-7100
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

A participant is eligible to participate if not pregnant, not planning to become pregnant, or is not breastfeeding and one of the following conditions applies: oIs not able to become pregnant OR oIs a person able to be pregnant (PABP) and using a contraceptive method that is highly effective, with a failure rate of \<1%. The investigator will evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first does of study intervention.
A PABP must have a highly sensitive negative urine pregnancy test at study entry and prior to each Experimental Session, see Schedule of Activities.

What this trial measures

  • Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total scorefrom Baseline (Visit 3) to Visit 16 (approximately 16 weeks post-baseline)

    To evaluate the efficacy of MDMA-assisted therapy (MDMA-AT) in reducing PTSD symptom severity in participants with co-occurring PTSD and Alcohol Use Disorder (AUD), as measured by the change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score (past 30 days) from Baseline (Visit 3) to Visit 16 (approximately 16 weeks post-baseline). The CAPS-5 total severity score ranges from 0 to 80 with higher scores reflecting worse PTSD symptom severity.