Active-controlled trial of a Ketamine Assisted Group Mindfulness intervention for Alcohol Use Disorder
Randomised, parallel-group Phase II trial (n=80) comparing oral ketamine (1.5 mg/kg) versus active control midazolam (0.05 mg/kg) given in weeks 3 and 5 within a 6‑week group mindfulness programme for moderate–severe Alcohol Use Disorder.
Details
Participants receive a manualised in‑person group mindfulness programme once weekly for six weeks (groups ≤10, delivered by two trained facilitators). Randomised arms receive oral ketamine or active control midazolam during the mindfulness sessions in weeks 3 and 5.
Primary outcome is self‑reported drinking days by timeline follow‑back to week 10; secondary measures include alcohol craving VAS, breathalyser at each session, blood tests for longer‑term alcohol use, and follow‑up phone calls at 3 and 6 months.