Clinical Trial

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

Study acronym: Psi or Ket
Recruiting Phase 2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2024-05-06; most recent amendment 2025-11-21.
Status change: Not Yet Recruiting → Recruiting 2025-07-09
Trial Details
NCT Number NCT06405607
Lead Sponsor University of Iowa
Conditions Alcohol Use Disorder, Alcohol Dependence, Alcohol Abuse
Enrollment 80 participants
Start Date 2025-06-12
Primary Completion 2028-04 (estimated)
Study Completion 2028-04 (estimated)
Updated on ClinicalTrials.gov 2025-11-28