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NCT07118839 · ClinicalTrials.gov registry record · Phase 2
MDMA-Assisted Therapy for Veterans With PTSD and Alcohol Use Disorder
A Phase 2 study, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
NCT07118839: Recruiting Phase 2 study, sponsored by VA Office of Research and Development.
NCT07118839 is a Phase 2 study that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07118839, a Phase 2 study, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
Study Summary
The study investigators are conducting the first randomized placebo-controlled trial of MDMA-assisted therapy with a comorbid sample of military Veterans with a co-occurring diagnosis of Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD). This novel experimental treatment package consists of three once-monthly Experimental Sessions of therapy combined with a divided-dose of MDMA HCl, along with non-drug preparatory and integrative therapy. The primary objective of the proposed project is to evaluate safety and clinical outcomes of MDMA-assisted therapy compared to identical psychotherapy with low dose ("active placebo") MDMA for the treatment of PTSD-AUD in military Veterans. The Primary Outcome measures, the Clinician Administered PTSD Scale (CAPS-5) and Inventory of Psychosocial Functioning (IPF), will evaluate changes in PTSD symptoms and psychosocial outcomes over time. Changes in drinking outcomes will also be evaluated (via the Timeline Followback, TLFB).
Primary Outcome
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.
Interventions
- DRUG Full Dose MDMA
- BEHAVIORAL MDMA-Assisted psychotherapy
- DRUG Active Placebo Dose MDMA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2026-05-18 |
| Est. Completion | 2030-05-30 |
| Phase | Phase 2 |
What NCT07118839 shows while recruiting
NCT07118839 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 3 interventions - of which Full Dose MDMA is the first listed.
NCT07118839 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07118839 about?
NCT07118839 is a clinical study titled "MDMA-Assisted Therapy for Veterans With PTSD and Alcohol Use Disorder". The study investigators are conducting the first randomized placebo-controlled trial of MDMA-assisted therapy with a comorbid sample of military Veterans with a co-occurring diagnosis of Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD). This novel experimental treatment package c...
What is the current status of trial NCT07118839?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2026-05-18. Estimated completion is 2030-05-30.
What interventions are being tested in trial NCT07118839?
The interventions under investigation include: Full Dose MDMA (DRUG), MDMA-Assisted psychotherapy (BEHAVIORAL), Active Placebo Dose MDMA (DRUG).
Who is sponsoring clinical trial NCT07118839?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07118839's enrollment target sits among peer trials
80 842nd of 2000 higher than 1,117 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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