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

NCT ID: NCT06405607

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-12
• Study Completion Date: 2028-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Psilocybin Group (Arm 1)

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

Group Type: EXPERIMENTAL

Psilocybin

Intervention Type: DRUG

30 mg single dose

Ketamine Group (Arm 2)

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

Group Type: ACTIVE_COMPARATOR

Ketamine

Intervention Type: DRUG

0.75 mg/kg weight-based single dose

Interventions

Psilocybin

30 mg single dose

Intervention Type: DRUG

Ketamine

0.75 mg/kg weight-based single dose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.
• No MRI contraindications

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.)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Iowa

OTHER

Sponsor Role: lead

Responsible Party

Peggy C Nopoulos

Department Chair, Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peggy C Nopoulos, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa Health Care

Iowa City, Iowa, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lindsay E Golden, BS

Role: CONTACT

lindsay-golden@uiowa.edu

319-384-5243

Peggy C Nopoulos, MD

Role: CONTACT

peggy-nopoulos@uiowa.edu

319-356-1144

Facility Contacts

Lindsay E Golden

Role: primary

lindsay-golden@uiowa.edu

Other Identifiers

202404714

Identifier Type: -

Identifier Source: org_study_id