Psilocybin-Assisted Psychotherapy for the Treatment of Severe Alcohol Use Disorder (NCT07296094) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Psilocybin-Assisted Psychotherapy for the Treatment of Severe Alcohol Use Disorder
United States36 participantsStarted 2026-06-15
Plain-language 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).
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* C…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent Heavy Drinking Days
Timeframe: Weeks 0-24 following the first psilocybin dosing session.
2
Adverse effects
Timeframe: 1, 2, 4, 8, 16, 24 and 48 weeks after receiving the second dose of the psilocybin treatment.
3
Cue-Induced Craving Response
Timeframe: Measured at baseline, 4 and 24 weeks after the second psilocybin treatment.
4
Neural Response and Connectivity Changes measured by fMRI
Timeframe: 1 week before and 1 week after the second psilocybin session
5
Neural Response and Connectivity Changes measured by fMRI
Timeframe: 1 week before and 1 week after the second psilocybin session
6
Neural Response and Connectivity Changes measured by fMRI
Timeframe: 1 week before and 1 week after the second psilocybin session