MDMA-assisted Prolonged Exposure Therapy for Comorbid Alcohol Use Disorder and Post-traumatic Stress Disorder (MPATHY)
This Phase II interventional trial (n=120) explores the effectiveness of MDMA-assisted (80–160 mg per session, with possible supplemental doses) prolonged exposure therapy (COPE) versus niacin control in individuals with comorbid PTSD and alcohol use disorder.
Details
Double-blind, randomised, placebo-controlled Phase II trial (n=120) comparing MDMA-assisted COPE (two oral MDMA dosing sessions, 80–160 mg per session with possible supplemental doses) to COPE with niacin control across 14 weeks including 12 COPE sessions.
Primary outcomes are change in PTSD symptom severity (CAPS-5) and heavy drinking; secondary outcomes include safety, tolerability, and functional measures. Investigators hypothesise greater reductions in PTSD symptoms and heavy drinking in MDMA-treated participants.