MedTrace Logo

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

NCT07118839 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-05-20

No results posted yet for this 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).

Conditions

Interventions

BEHAVIORAL

MDMA-Assisted psychotherapy

inner-directive psychotherapy will be conducted throughout the study; Integrative MDMA-Assisted Psychotherapy (IMAP) for PTSD Therapy Manual.

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).

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 \[0 mg midomafetamine HCl\]).

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-18
Primary Completion
2030-05-01
Completion
2030-05-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07118839 on ClinicalTrials.gov