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Not yet recruitingPhase 2

Psilocybin-Assisted Psychotherapy for the Treatment of Severe Alcohol Use Disorder

NCT07296094 · Brigham and Women's Hospital

Closed to entry
Status
Not accepting participants
Phase 2
Phase
36
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

This study aims to determine the safety and preliminary efficacy of psilocybin-assisted psychotherapy in improving alcohol-related outcomes among adults with severe alcohol use disorder in a a double-blind, dose-comparison concurrent control, randomized trial. Participants will undergo structured psychotherapy and will be randomized to two psilocybin sessions to receive either a full dose (30mg or 40mg) or low dose (10mg or 15mg).

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Percent Heavy Drinking Days

    Measured over Weeks 0-24 following the first psilocybin dosing session.

  • Adverse effects

    Measured over 1, 2, 4, 8, 16, 24 and 48 weeks after receiving the second dose of the psilocybin treatment.

  • Cue-Induced Craving Response

    Measured over Measured at baseline, 4 and 24 weeks after the second psilocybin treatment.

  • Neural Response and Connectivity Changes measured by fMRI

    Measured over 1 week before and 1 week after the second psilocybin session

  • Neural Response and Connectivity Changes measured by fMRI

    Measured over 1 week before and 1 week after the second psilocybin session

  • Neural Response and Connectivity Changes measured by fMRI

    Measured over 1 week before and 1 week after the second psilocybin session

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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.

Where

1 study site

FacilityCityRegionCountry
Brigham and Women's HospitalBostonMassachusettsUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT07296094 on ClinicalTrials.gov →

Last updated in the registry 2026-08-13. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits