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

NCT05421065 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 202205036
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Use Disorder

Keywords

psilocybin; ketamine

Outcome Measures

Primary Outcomes (1)

• Timeline Follow-Back for Alcohol to assess change

  quantifies daily alcohol use

  weekly, over the course of 8 weeks

Secondary Outcomes (2)

• T1rho

  three times (before intervention, immediately after intervention, and 4 weeks-post intervention)

• Resting state fMRI

  three times (before intervention, immediately after intervention, and 4 weeks-post intervention)

Other Outcomes (2)

• Feasibility and acceptability of the protocol

  1 year

• Feasibility and acceptability of the protocol

  1 year

Study Arms (2)

Psilocybin Group (Arm 1)

EXPERIMENTAL

Drug: Psilocybin

Ketamine Group (Arm 2)

ACTIVE COMPARATOR

Drug: Ketamine

Interventions

Psilocybin DRUG

1 oral dose

Psilocybin Group (Arm 1)

Ketamine DRUG

1 oral dose

Ketamine Group (Arm 2)

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Male
• English fluency
• Meets criteria for DSM-V moderate or severe AUD.
• Have at least 4 heavy drinking days (5 or more standard drinks in a day) in the past 30 days.
• 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
• No current substance use disorder other than AUD
• Negative drug screen (other than THC) on drug administration day
• No prescription medications classified as UGT1A9 inhibitors, UGT1A10 inhibitors, aldehyde or alcohol dehydrogenase inhibitors.
• At least a high-school level of education or equivalent (e.g. GED).
• Lived at current residence for at least 3 months.
• Family member/friend for pick-up, overnight post-drug session monitoring.
• No hallucinogen or ketamine use in past 1 year
• No self-reported, personal, or familial history of specific psychotic disorders/episodes as subjects who take psilocybin may experience a worsening and/or persistent psychotic state. Therefore, these subjects are excluded due to an abundance of caution since even a family history may create a vulnerability to psychosis.

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 including cocaine, psychostimulant, or opioid use disorder within past 12 months and/or any use within past 30 days, 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).
• MRI contraindication (pacemaker, etc.)

Sponsors & Collaborators

• Peggy C Nopoulos: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (3)

• Davis AK, Barrett FS, May DG, Cosimano MP, Sepeda ND, Johnson MW, Finan PH, Griffiths RR. Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2021 May 1;78(5):481-489. doi: 10.1001/jamapsychiatry.2020.3285.

  PMID: 33146667 BACKGROUND

• Bogenschutz MP, Forcehimes AA, Pommy JA, Wilcox CE, Barbosa PC, Strassman RJ. Psilocybin-assisted treatment for alcohol dependence: a proof-of-concept study. J Psychopharmacol. 2015 Mar;29(3):289-99. doi: 10.1177/0269881114565144. Epub 2015 Jan 13.

  PMID: 25586396 BACKGROUND

• Johnson M, Richards W, Griffiths R. Human hallucinogen research: guidelines for safety. J Psychopharmacol. 2008 Aug;22(6):603-20. doi: 10.1177/0269881108093587. Epub 2008 Jul 1.

  PMID: 18593734 BACKGROUND

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: June 12, 2022
• First Posted: June 16, 2022
• Study Start: February 2, 2024
• Primary Completion: August 30, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)