Psilocybin Vs Ketamine for Alcohol Use Disorder

Phase 2

Not yet recruiting

• Conditions: Alcohol Use Disorder; Alcohol Dependence; Alcohol Abuse
• Interventions: Drug: Psilocybin; Drug: Ketamine

• Registration Number: NCT06405607
• Lead Sponsor: University of Iowa

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-02
• Study First Submitted QC: 2024-05-06
• Study First Posted: 2024-05-08
• Status Verified: 2024-10
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-11
• Study Start: 2025-04
• Primary Completion: 2028-04
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psilocybin Group (Arm 1)	Psilocybin	receives individual psychotherapy sessions plus a (30 mg) psilocybin session.
Ketamine Group (Arm 2)	Ketamine	receives individual psychotherapy sessions plus a (0.75 mg/kg) ketamine session

Primary Outcome Measures

Name	Time	Method
Timeline Follow-Back for Alcohol to assess change	Weekly, over the course of 16 weeks	Quantifies daily alcohol use

Secondary Outcome Measures

Name	Time	Method
Resting state fMRI	Twice (before intervention, post intervention):: at week 1 and week 16	Measures biological changes in brain resting state global functional connectivity
T1rho	Twice (before intervention, post intervention): at week 1 and week 16	Measures biological changes in the brain
EEG- signal complexity	Twice (before drug administration and at peak of drug experience) during week 3	Measures electrical signal change