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 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).

NCT Number	NCT07118839
Lead Sponsor	VA Office of Research and Development
Conditions	Post Traumatic Stress Disorder, Alcohol Use Disorder
Enrollment	80 participants
Start Date	2026-05-18
Primary Completion	2030-05-01 (estimated)
Study Completion	2030-05-30 (estimated)
Updated on ClinicalTrials.gov	2026-06-02