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Magic mushroom therapy slashes heavy drinking in new trial

NCT ID NCT05416229

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a single high dose of psilocybin (the active ingredient in magic mushrooms) combined with psychological support could help people with alcohol use disorder drink less. 60 adults in Denmark who were heavy drinkers took part. The main goal was to see if the treatment reduced the number of heavy drinking days over 28 days.

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

60 people

The number who actually took part.

Started

Sep 2023

Finished

Dec 2025

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

20 to 70 years

Sex

Anyone

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: * Bodyweight of 50-110 kg * AUD according to DSM-5 criteria and alcohol dependence according to ICD-10. * AUD Identification Test (AUDIT) ≥ 15. * ≥ 5 heavy drinking days in the past 28 days prior to inclusion. Exclusion Criteria: * Current or previously diagnosed with any psychotic disorder or bipolar affective disorder. * Immediate family member with a diagnosed psychotic disorder. * History of delirium tremens or alcohol withdrawal seizures. * History of suicide attempt or present suicidal ideation at screening. * Withdrawal symptoms at screening (\>nine on the Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar) (43). * Present or former severe neurological disease including trauma with loss of consciousness \> 30 min. * Impaired hepatic function (alanine transaminase \>210/135 units/l men/women) * Cardiovascular disease defined as decompensated heart failure (NYHA class III or IV), unstable angina pectoris, myocardial infarction within the last 12 months or uncontrolled hypertension (systolic blood pressure \>165 mmHg, diastolic blood pressure \>95 mmHg). * Present or former abnormal QTc (\>450/470 ms men/women). * Treatment with disulfiram, naltrexone, acamprosate and nalmefene within 28 days of inclusion. * Treatment with any serotonergic medication or drugs within one month prior inclusion. * Any oOther active substance use disorders (except nicotine) defined as a Drug Use Disorder Identification Test score \>six/two (men/women) and investigator's clinical evaluation. * Women who are pregnant, breastfeeding, or intend to become pregnant or are not using adequate contraceptive measures considered highly effective (44). * Unable to speak or understand Danish. * Any other condition that the clinician estimates can interfere with trial participation.

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Conditions

The condition(s) this trial relates to.

alcohol abuse Behavior, Addictive

As listed by the trial registrant

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

Contacts and locations

Locations

  • Psychiatric Center Copenhagen, Frederiksberg Hospital

    Frederiksberg, 2000, Denmark

More trials for these conditions

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