Psilocybin-Assisted vs Ketamine-Assisted Psychotherapy for Alcohol Use Disorder

This double-blind, randomized, active-comparator controlled trial (n=20) will compare the effects of psilocybin-assisted psychotherapy with ketamine-assisted psychotherapy in individuals struggling with alcohol use disorder (AUD).

Conducted by Peggy C. Nopoulos at the University of Iowa, the study aims to assess the efficacy of these two interventions in reducing alcohol use and improving overall well-being.

Participants will be male adults aged 25 to 50 with moderate to severe AUD and at least four heavy drinking days in the past month. They will undergo individual psychotherapy sessions alongside either a 25mg dose of psilocybin or a 200mg dose of ketamine.

The primary outcome measure is the Timeline Follow-Back for Alcohol, assessing daily alcohol use over eight weeks. Secondary outcomes include biological changes in the brain measured via MRI scans, feasibility, and acceptability of the protocol.

Recruitment started in February 2024, and the study is estimated to complete in February 2025.

Topic Alcohol Use Disorder Addiction
Compound Psilocybin Ketamine
Country United States of America
Visit trial
Status Recruiting
Results Published No
Start date 02 February 2024
End date 28 February 2025
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 20
Sex Male
Age 25- 50
Therapy Yes

Trial Details

This pilot study will collect preliminary data that measures the effects of psilocybin-assisted psychotherapy vs ketamine-assisted psychotherapy on patients struggling with alcohol use.

NCT Number NCT05421065

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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