This double-blind, randomised, controlled trial (n=280) will investigate the efficacy of ketamine-assisted psychological therapy in severe alcohol use disorder (AUD) patients.
Multi-centre, double-blind randomised parallel-group Phase III trial comparing three weekly IV ketamine infusions (0.8 mg/kg) with low-dose ketamine (0.05 mg/kg) in people with severe AUD, combined with seven sessions of psychological support.
Primary outcome is number of heavy drinking days at six months (TLFB), with corroborating measures including breathalyser, continuous transdermal monitoring and urine biomarkers; secondary outcomes include abstinence, liver biomarkers, functioning, depressive symptoms, craving and health-economic measures.
Participants receive three 40-minute IV infusions (one per week) and seven psychological support sessions (therapy or alcohol education); randomisation and allocation performed via REDCap Academic.
Three weekly IV infusions of ketamine 0.8 mg/kg plus psychological support.
Three 40-minute IV infusions (one per week).
Three weekly IV infusions of low-dose ketamine (active comparator) plus psychological support.
Three 40-minute IV infusions (one per week); low-dose active comparator.