Psilocybin vs Ketamine for Alcohol Use Disorder (Psi vs Ket)

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.

Topic Alcohol Use Disorder Addiction
Compound Psilocybin Ketamine
Country United States of America
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 June 2024
End date 30 June 2027
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 80
Sex Male
Age 25- 65
Therapy Yes

Trial Details

This study will collect data that measures the effects of a psychedelic intervention on patients struggling with alcohol use disorder (AUD). The study design will be a double blind, randomized, active-comparator trial with two study arms. Subjects randomized to Arm 1 (n=40) will receive individual psychotherapy sessions plus a 30 mg dose of oral psilocybin. Arm 2 subjects (n=40) will receive individual psychotherapy sessions and a 0.75 mg/kg dose of intramuscular ketamine.

NCT Number NCT06405607

Sponsors & Collaborators

University of Iowa
The Niciu Lab at the University of Iowa is interested in the therapeutic effects of ketamine.

Data attribution

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