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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. 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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07118839
The ClinicalTrials.gov registry entry for NCT07118839 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Full Dose MDMA is the first listed.
NCT07118839 reports 0 study locations.
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.
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