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.
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.
Oral ketamine administered within manualised group mindfulness sessions (weeks 3 and 5).
Oral solution in juice given during weeks 3 and 5 of the 6‑week mindfulness programme.
Oral midazolam as active control administered within mindfulness sessions (weeks 3 and 5).
0.05 mg/kg in 50 mL orange juice given during weeks 3 and 5 (active control; compound recorded as placebo reference).