Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Psychedelic showdown: psilocybin vs ketamine for heavy drinkers

NCT ID NCT05421065

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tests whether a single dose of psilocybin or ketamine, combined with psychotherapy, can help men with moderate to severe alcohol use disorder drink less. Twenty men aged 25-65 will receive one of the two drugs and be followed for changes in drinking habits and brain activity. The goal is to gather early data on which approach might work better.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Psilocybin and ketamine (each given as a single oral dose alongside psychotherapy)
What this could lead to
If this works, it could point toward a new way to help people reduce heavy drinking by combining a psychedelic drug with talk therapy.
What could go wrong
This is a very small pilot study with only 20 men, so results may not apply to everyone. It is too early to know if either treatment is truly effective or safe for alcohol use disorder.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

25 to 65 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 25-65 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. * No serious traumatic brain injury (TBI) in the past 2 years. * No known allergies to rescue medication (diazepam) * Weight between 110 and 330 lbs 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 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.)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Alcohol use disorder are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Iowa

    Iowa City, Iowa, 52242, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.