This double-blind, randomised, active-comparator trial (n=80) will study the effects of psilocybin (30mg) versus ketamine (52.5mg/70kg) for alcohol use disorder (AUD).
Conducted by the University of Iowa and led by Dr Peggy C Nopoulos, the study will involve two arms: Arm 1 (n=40) receiving individual psychotherapy sessions plus a 30 mg dose of oral psilocybin, and Arm 2 (n=40) receiving individual psychotherapy sessions plus a 0.75 mg/kg dose of intramuscular ketamine.
The primary outcome measure is the Timeline Follow-Back for Alcohol to assess changes in alcohol use over 16 weeks. Secondary measures include T1rho for biological brain changes, resting state fMRI for global functional connectivity, and EEG-signal complexity.
The study, scheduled to start in June 2024 and complete by June 2027, aims to provide insights into the efficacy and safety of these psychedelic interventions for AUD.
Trial Details
Trial Number
Sponsors & Collaborators
University of IowaThe Niciu Lab at the University of Iowa is interested in the therapeutic effects of ketamine.