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.
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.
COPE (prolonged exposure) plus MDMA-assisted dosing (two sessions)
Prolonged Exposure therapy (COPE): 12 individual 90-minute sessions (12 x 90 min). Delivered by clinical psychologist; integrated CBT for PTSD and AUD.
Per-session dosing delivered as initial 2x80mg capsules with optional supplemental 40mg (session 1) or 40–80mg (session 2); clinician-participant consensus; supplemental dose 60–90 minutes after initial dose.
COPE plus niacin active-control (niacin 250 mg or niacin-matched placebo)
Prolonged Exposure therapy (COPE): 12 individual 90-minute sessions.
Niacin 250 mg or niacin-matched placebo given to match dosing sessions.