NCT06405607

Psilocybin or Ketamine for Alcohol Use Disorder: An Active Comparator Trial

Psilocybin vs Ketamine for Alcohol Use Disorder

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Iowa · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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 psilocybin. Arm 2 subjects (n=40) will receive individual psychotherapy sessions and a 0.75 mg/kg dose of ketamine.

Conditions

• Alcohol Use Disorder
• Alcohol Dependence
• Alcohol Abuse

Interventions

Type	Name	Description
DRUG	Psilocybin	30 mg single dose
DRUG	Ketamine	0.75 mg/kg weight-based single dose

Timeline

• Start date: 2025-06-12
• Primary completion: 2028-04-01
• Completion: 2028-04-01
• First posted: 2024-05-08
• Last updated: 2025-11-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study