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Psilocybin or Ketamine for Alcohol Use Disorder

This study is looking at how two psychedelic medicines, psilocybin and ketamine, might help people with Alcohol Use Disorder (AUD). You could be eligible if you are between 21 and 65 years old, weigh between 50kg and 150kg, and have moderate to severe AUD with at least four heavy drinking days in the past month. If you can become pregnant, you must not be pregnant and be using birth control. The study aims to see how much alcohol use changes over 16 weeks. This is a double-blind study, meaning neither you nor the study team will know which medicine you receive. The study plans to enroll 80 people, with 40 receiving psilocybin and 40 receiving ketamine, both alongside individual therapy. The current recruitment status is unclear.

Study design
This is a double-blind, randomized study with two groups, aiming to enroll 80 participants. One group will receive psilocybin and the other will receive ketamine.
What's involved
Participants will receive individual psychotherapy sessions and a single dose of either psilocybin or ketamine. Alcohol use will be assessed weekly over 16 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants' alcohol use will be followed weekly over the course of 16 weeks.

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NCT06405607

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

Recruiting
PHASE2Ages 21–65InterventionalTreatment
University of Iowa
~80 participants
Updated 2025-11-28 on ClinicalTrials.gov
What's tested:PsilocybinKetamine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Timeline Follow-Back for Alcohol to assess change
Measured over Weekly, over the course of 16 weeks

Conditions

Alcohol Use Disorder
Alcohol Dependence
Alcohol Abuse

Explore related trials

Alcohol use disorder

Where it's being run

1 sites across 1 states
Iowa1

Study leadership

  • Peggy C Nopoulos, MD · PRINCIPAL_INVESTIGATOR · University of Iowa

Who to contact

Lindsay E Golden, BS
[email protected]
319-384-5243
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

What this trial measures

  • Timeline Follow-Back for Alcohol to assess changeWeekly, over the course of 16 weeks

    Quantifies daily alcohol use