Ketamine for Reduction of Alcoholic Relapse (KARE)
Randomised, parallel-group, Phase II trial (n=96) comparing three sessions of ketamine (0.8 mg/kg IV over 45 minutes) versus placebo, each combined with either manualised psychological therapy or simple alcohol education in recently detoxified participants with alcohol use disorder.
Details
This is a randomised, quadruple-blind, parallel-group Phase II trial enrolling recently detoxified participants with alcohol use disorder to compare three 0.8 mg/kg IV ketamine infusions (45 minutes) versus saline placebo, each paired with either manualised CBT relapse-prevention or simple alcohol education.
Primary outcomes are percent days abstinent and relapse rates at 6 months; secondary outcomes include depressive symptoms, craving and quality of life. Assessments occur acutely and at 3 and 6 months with biological and psychological measures.