This triple-blinded, randomised, active placebo-controlled trial (n=34) will investigate IV ketamine (0.8 mg/kg, four infusions over two weeks) versus midazolam in adults with moderate depression and alcohol use disorder admitted for inpatient addiction therapy.
Randomised, triple-blind, parallel-group trial (n=34) comparing IV ketamine 0.8 mg/kg to active placebo midazolam 0.02 mg/kg; four infusions given twice weekly over two weeks alongside standard inpatient addiction therapy.
Primary and secondary outcomes include depressive symptoms (MADRS, BDI-II), alcohol use and craving (TLFB, ACQ-Short, PACS), neurocognitive function (CANTAB), safety/tolerability (mKSET, AEs/SAEs) and exploratory measures of quality of life and subjective experience (MEQ30, EDI, EBI).
Assessments occur at baseline, acutely and at multiple follow-ups (1–2 days, 1 week, 2 weeks, 4 weeks) with a final follow-up at 6 months to evaluate lasting effects on depression and alcohol use disorder.
IV ketamine infusions 0.8 mg/kg given twice weekly for two weeks (four total infusions).
IV infusions over 40 minutes
Active placebo: IV midazolam 0.02 mg/kg given on same schedule as ketamine.
Midazolam 0.02 mg/kg IV over 40 minutes (active comparator)