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

NCT06405607 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 202404714
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

psychedelic; psilocybin; ketamine

Outcome Measures

Primary Outcomes (1)

• Timeline Follow-Back for Alcohol to assess change

  Quantifies daily alcohol use

  Weekly, over the course of 16 weeks

Secondary Outcomes (3)

• T1rho

  Twice (before intervention, post intervention): at week 1 and week 16

• Resting state fMRI

  Twice (before intervention, post intervention):: at week 1 and week 16

• EEG- signal complexity

  Twice (before drug administration and at peak of drug experience) during week 3

Study Arms (2)

Psilocybin Group (Arm 1)

EXPERIMENTAL

receives individual psychotherapy sessions plus a (30 mg) psilocybin session.

Drug: Psilocybin

Ketamine Group (Arm 2)

ACTIVE COMPARATOR

receives individual psychotherapy sessions plus a (0.75 mg/kg) ketamine session

Drug: Ketamine

Interventions

Psilocybin DRUG

30 mg single dose

Psilocybin Group (Arm 1)

Ketamine DRUG

0.75 mg/kg weight-based single dose

Ketamine Group (Arm 2)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Weight between 50kg and 150kg
• No known allergies to rescue medication
• For people capable of becoming pregnant, not pregnant and using contraception
• Not currently breastfeeding
• Meets criteria for DSM-V moderate to severe AUD.
• Have at least 4 heavy drinking days (5 or more standard drinks in a day) in the past 30 days.
• Not currently participating in formal treatment for AUD.
• No history of a of cerebrovascular accident, asthma, or significant alcohol withdrawal history
• No seizure disorder, coronary artery disease, heart failure, uncontrolled hypertension, insulin-dependent diabetes, pancreatitis, liver disease
• No hallucinogen or ketamine use in past 12 months
• No self-reported, personal, or familial history of specific psychotic disorders/episodes.
• No serious traumatic brain injury (TBI) in the past 2 years
• No substance use disorder other than AUD over the past 12 months
• If taking a GLP-1 agonist, stable dosage for past 3 months
• Family member/friend for pick-up, overnight post-drug session monitoring.

You may not qualify if:

• Drug/medication assessment that yields: nonprescription medication use, nutritional supplement, or herbal supplement (except when approved by the study investigators), medically unstable, current medication use that has significant potential to interact with study drug (e.g., antidepressants, antipsychotics, psychostimulants, treatments for addictions, other dopaminergic or serotonergic agents, lithium, anticonvulsants, or benzodiazepines).
• Psychiatric assessment that yields:1) history of severe suicide attempt, 2) current suicidality 3) first-degree relative with schizophrenia or schizoaffective disorder, 4) comorbid substance use disorder including cocaine, psychostimulant, or opioid use disorder within past 12 months 5) history of co-occurring psychotic episode/diagnosis including schizophrenia, schizoaffective disorder, schizophreniform, substance-induced psychosis, delusional disorder, or psychosis not otherwise specified, 6) high risk of adverse emotional or behavioral reaction based on the medical monitor's clinical evaluation that may also yield evidence of serious current stressors, a lack of meaningful social support, antisocial behavior, and/or serious personality disorders amongst other conditions.
• Medical assessment that yields: serious ECG abnormalities (evidence of ischemia, myocardial infarction, QTc prolongation \[QTc \> .045\]), serious abnormalities of complete blood count or chemistries, medical conditions that would preclude safe participation (significantly impaired liver function), or pregnancy.
• MRI contraindication (pacemaker, etc.)

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa Health Care

Iowa City, Iowa, 52240, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism

Interventions

Psilocybin; Ketamine

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Peggy C Nopoulos, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsay E Golden, BS

CONTACT

319-384-5243; lindsay-golden@uiowa.edu

Peggy C Nopoulos, MD

CONTACT

319-356-1144; peggy-nopoulos@uiowa.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Chair, Psychiatry

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 8, 2024
• Study Start: June 12, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

US (1)