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

Recruiting now · Phase 2

Conditions studied: Alcohol Use Disorder, Alcohol Dependence, Alcohol Abuse

In brief

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.

Key facts

Study ID: NCT06405607
Run by: University of Iowa
People needed: 80
Starts: 2025-06-12
Expected to finish: 2028-04-01
Last updated by the study team: 2025-11-28

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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.
No MRI contraindications

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.)

Where it is running

University of Iowa Health Care — Iowa City, Iowa, United States (enrolling)

Full record on ClinicalTrials.gov

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