NCT07118839

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

MDMA-Assisted Therapy for Veterans With PTSD and Alcohol Use Disorder: A Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The study will use a longitudinal design to conduct a randomized controlled trial of MDMA-AT for Veterans with PTSD-AUD. Eligible participants will complete an in-person baseline assessment, engage in MDMA-assisted therapy or identical psychotherapy with low dose ("active placebo") MDMA with trained therapist dyads, and complete assessments at post-treatment, 3-, and 6-month follow-ups. For complete description of the investigational plan, please the attached Clinical Protocol.

Conditions

• Post Traumatic Stress Disorder
• Alcohol Use Disorder

Interventions

Type	Name	Description
DRUG	Full Dose MDMA	During the three Experimental Sessions, participants will receive a split dose of 180 mg midomafetamine hydrochloride salt (MDMA HCl) administered orally (2 × 60 mg midomafetamine HCl capsules, followed approximately 1.5 to 2 hours later by 1 × 60 mg midomafetamine HCl capsule).
BEHAVIORAL	MDMA-Assisted psychotherapy	inner-directive psychotherapy will be conducted throughout the study; Integrative MDMA-Assisted Psychotherapy (IMAP) for PTSD Therapy Manual.
DRUG	Active Placebo Dose MDMA	During the three Experimental Sessions, participants will receive a split dose of 40 mg midomafetamine HCl administered orally (1 × 40 mg midomafetamine HCl capsules and 1 x placebo capsule \[0 mg midomafetamine HCl\], followed 1.5 to 2 hours later by 1 × placebo capsule \[0 mg midomafetamine HCl\]).

Timeline

• Start date: 2026-04-15
• Primary completion: 2030-05-01
• Completion: 2030-05-30
• First posted: 2025-08-12
• Last updated: 2026-04-07

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study