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

NCT06405607 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-11-28

No results posted yet for this study

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

Interventions

DRUG

Psilocybin

30 mg single dose

DRUG

Ketamine

0.75 mg/kg weight-based single dose

Sponsors & Collaborators

  • University of Iowa

    lead OTHER

Principal Investigators

  • Peggy C Nopoulos, MD · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-12
Primary Completion
2028-04-30
Completion
2028-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06405607 on ClinicalTrials.gov