MDMA-Assisted Therapy for Veterans With PTSD and Alcohol Use Disorder (NCT07118839) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
MDMA-Assisted Therapy for Veterans With PTSD and Alcohol Use Disorder
United States80 participantsStarted 2026-04-15
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Are at least 18 years old at the time of signing the informed consent.
✓. Are currently enrolled in VA care.
✓. Veterans must have initiated and discontinued (or completed) at least one first-line evidence-based treatment (EBT) for PTSD alone, for PTSD and AUD together, or for a dual-diagnosis condition, as documented in CPRS.
✓. Are fluent in speaking and reading English.
✓. At Screening, Veterans must meet past 3-month criteria for Alcohol Use Disorder as measured by the SCID-5.
✓. Must have a desire to abstain or reduce alcohol use, per Veteran report.
✓. Able to safely abstain from alcohol for at least 48 hours without requiring medical detox.
✓. At Screening (V0) have a confirmed diagnosis of PTSD with symptom duration of at least 6 months and a total severity score of \>28 per the CAPS-5.
Exclusion criteria
✕. Have symptomatic liver disease or have significant liver enzyme elevations.
What they're measuring
1
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score
Timeframe: from Baseline (Visit 3) to Visit 16 (approximately 16 weeks post-baseline)
✕. Alanine transaminase (ALT) or aspartate transaminase (AST) \> 3 x upper limit of normal (ULN).
✕. Total bilirubin \> 1.5 x ULN or direct bilirubin \< 35%.
✕. Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
✕. Moderate or severe chronic kidney disease, defined as Estimated Glomerular Filtration Rate (eGFR)\<60 mL/min at screening or end stage renal disease on dialysis.
✕. Have a history of seizures or delirium tremens.
✕. Significant alcohol withdrawal symptoms, defined as a Clinical Institute Withdrawal Assessment of alcohol scale, revised (CIWA-Ar) \>10.
✕. Have a recent history of clinically significant hyponatremia or hyperthermia.