Magic mushroom therapy slashes heavy drinking in new trial
NCT ID NCT05416229
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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60 people
The number who actually took part.
- Started
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Sep 2023
- Finished
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Dec 2025
- Lead sponsor
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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
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20 to 70 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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
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Other studies related to the condition(s) this trial covers.
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