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Magic mushroom therapy targets heavy drinking in new trial

NCT ID NCT07296094

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 14, 2026 · Updated 2 times

Summary

This study tests whether psilocybin (the active ingredient in magic mushrooms) combined with talk therapy can help people with severe alcohol use disorder reduce heavy drinking. Thirty-six adults who recently completed detox will receive either a high or low dose of psilocybin during two therapy sessions. Researchers will track drinking patterns, cravings, and brain activity to see if the higher dose works better and is safe.

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 36 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Feb 2030

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

18 to 65 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.

To be eligible, individuals must be: * English speaking adults between ages 18 and 65 * Diagnosis of DSM5 AUD, severe * Completion of inpatient withdrawal management (i.e. "detox") for AUD within 90 days of enrollment * Amenable to attending all psychotherapy and study visits at BWH CCI * Able to identify an individual who can act as points of contact during the trial * Have a friend or family member who can bring the participant home after the psilocybin sessions and stay overnight Individuals with any of the following will be excluded: * • Any personal history of a psychotic disorder (schizophrenia, schizoaffective disorder, brief psychotic disorder, delusional disorder, schizophreniform disorder, substance-induced psychotic disorder or major depression with psychotic features) or any bipolar-spectrum disorder * Participants with a family history of first-degree relatives with psychotic disorder or bipolar-spectrum disorder * Participants who have a significant suicide risk as defined by current suicidal ideation (Columbia-Suicide Severity Rating Scale (C-SSRS) score 2 to 5) and/or recent (within the past 6 months) active suicidal ideation (C-SSRS score 4 or 5) * Participants who have a history of significant or serious adverse reaction to classic psychedelics * Homicidality within the last six months * History of DSM5 hallucinogen use disorder * Positive breath alcohol level at screening * Need for inpatient withdrawal management for alcohol at the time of screening * Current DSM5 opioid, cocaine, stimulant or sedative/hypnotic use disorder * Systolic blood pressure persistently above 165mmHg during screening * History of hypersensitivity to psilocybin * Use of psilocybin or other psychedelics with 5-HT2B activity in the prior 12 months * Significant EKG abnormalities including QTc prolongation defined as \>450 ms for men and women, or a diagnosis or family history of Long QT syndrome. * History of any cardiac valvulopathy that raises the risk for participation as determined by the cardiology consultant * History of intracranial mass or bleed, seizure disorder other than alcohol withdrawal seizures, liver cirrhosis, renal failure, obstructive lung disease requiring supplemental oxygen, hyperthyroidism, narrow-angle glaucoma, uncontrolled cardiac arrythmias, heart failure * History of head trauma, stroke, or myocardial infarction in one year prior to enrollment. * Expected to require surgical treatment at any point during the trial * Liver dysfunction with LFTs \> 3x upper normal limit at screening and Total bilirubin \> 2.5x the upper normal limit * MRI contraindications (other ferromagnetic implants, body weight greater than 550 lbs., etc.) * Pregnant or breastfeeding * High risk for adverse emotional or behavioral reaction based on the opinion of the study investigators such as evidence of a personality disorder * Currently taking medications with serotonergic activity (other than SSRIs/SNRIs); inhibitors of UGT1A9, UGT1A10, MAO, and aldehyde or alcohol dehydrogenase; antipsychotics (e.g., first and second generation); mood stabilizers (e.g., lithium, valproic acid); or significant inhibitors of UGT enzymes that metabolize psilocin * Selective serotonergic reuptake inhibitors and serotonin and norepinephrine reuptake inhibitors are allowed if participants have been on stable doses of the medication(s) for at least 90 days prior to enrollment. * Currently receiving insulin for blood sugar management.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

More trials for these conditions

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