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Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD

Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for Alcohol Use Disorder

NCT06349083•NYU Langone Health

Summary

This is a double-blind, randomized, placebo-controlled Phase 2 mechanistic clinical trial designed to evaluate the therapeutic neural mechanisms of psilocybin in patients with alcohol use disorder (AUD), and to determine whether further studies are warranted to study the relationship of any such effects to clinical improvement in AUD symptoms. The primary aims are to evaluate the effects of psilocybin on AUD; measures will include 1) fMRI neural activation and functional connectivity, using a well-validated task to characterize neural and subjective response to negative affective and alcohol visual stimuli; 2) alcohol use data (self-report and blood biomarkers); and 3) self-report measures related the NE, IS, and EF domains.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Are able to provide voluntary informed consent
•2. Have a breath alcohol concentration (BrAC) ≤ 0.01% at screening, as determined by a breath alcohol reading from a calibrated breath alcohol sensor. (Note: this criterion may be re-evaluated within the 30-day screening period. This criterion will also be reassessed at Baseline, on Day 0, and on Day 2. Those not meeting the criterion may be rescheduled once within 14 days if the criterion is likely to resolve within 14 days in the judgement of the Investigator).
•3. Are able to read, speak, and understand English, as documented during the informed consent process.
•a. Non-English speaking subjects will be excluded because the study is using only validated English-language versions of assessment instruments.
•4. Are 18 to 65 years old, inclusive, at Screening visit.
•5. Have DSM-5 diagnosis of moderate or severe Alcohol Use Disorder (AUD) (using MINI)
•6. Are in treatment at Silver Hill Hospital (either in Residential Treatment program, or Inpatient with plan to enter Residential Treatment Program)
•7. Are able and willing to adhere to all study requirements, including attending all study visits and therapy sessions, and completing all assessments.
•8. Have least 4 heavy drinking days (4 or more drinks per day for a woman, 5 or more drinks per day for a man) in the 30 days prior to admission to SHH
•9. Agree to refrain from any non-prescribed psychotropic substance or illicit drug use for at least 72 hours prior to investigational product (IP) administration, and for at least 24 hours before each fMRI assessment visit, with the exceptions of nicotine and caffeine. Regarding nicotine, they must agree not to use nicotine for at least 1 hour before and 6 hours following IP administration, and for at least 1 hour before fMRI scans. Regarding caffeine, they must agree to consume approximately their usual amount of caffeine on the morning of Day 0 (prior to IP administration).
+5 more criteria

Exclusion Criteria

•1. Pregnancy or lactation
•2. Any medical condition that would preclude safe participation in the study, including the following, as determined by medical history review, physical examination, electrocardiogram (ECG), and clinical laboratory tests:
•a. Seizure disorder ii. Significantly impaired liver function, defined as 1) alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 5 × upper limit of normal (ULN); 2) ALT or AST \> 3 × ULN with concomitant total bilirubin \> 2.0 × ULN; or 3) ALT or AST ≥ 3 × ULN with the appearance of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia.
•iii. Cardiovascular disease including coronary artery disease, angina, history of arrhythmia (unless a successful ablation has been performed), heart failure, history of heart valve replacement, and history of cerebrovascular accident or transient ischemic attack.
•iv. Uncontrolled hypertension with systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg. (Note: participants who otherwise qualify at the Screening visit will have 3 opportunities to produce 1 blood pressure reading ≤ 140/90 mmHg (each reading will be collected at least 15 minutes apart). If blood pressure the Screening visit is consistently elevated \> 140/90 mmHg across all 3 attempts, participants may be referred to their primary care provider for management of hypertension. Upon management of blood pressure, participants will have an opportunity to return once within the 30 day screening window to make 3 additional attempts at a blood pressure reading ≤ 140/90 mmHg. Participants will be considered eligible upon registering 1 blood pressure reading ≤ 140/90 mmHg during the Screening period.) v. Resting heart rate \> 100 bpm (Note: participants will have an opportunity to return once within the 30 day screening window to make 3 additional attempts at a resting heart rate ≤ 100 bpm.).
•vi. Serious ECG abnormalities present on the ECG obtained on Day -65 (e.g., evidence of ischemia, myocardial infarction, QT interval corrected for heart rate \[QTc\] prolongation (QTc \> 0.450 seconds), arrhythmia, or conduction abnormalities that increase the risk of arrhythmia.
•vii. Hyperthyroidism viii. Insulin-dependent diabetes ix. Any other medical condition which precludes safe participation in the study in the medical opinion of the Investigator. (Note: medical history will be updated on Day 0. Those not meeting the criterion will not be randomized but may be rescheduled once within 14 days if the criterion is likely to resolve within 14 days in the judgement of the Investigator.)
•3. Have any of the following DSM-5 psychiatric disorders, as determined by the MINI and Psychiatric History AT the Screening Visit: (Note: psychiatric history will be re-evaluated on Day 0, but the MINI will not be re-administered on Day 0)
•1. Lifetime history of schizophrenia spectrum or other psychotic disorder (including substance or medication-induced psychosis or psychosis due to a co-occurring medical condition).
•2. Current alcohol withdrawal (CIWA-Ar score \>7)
+16 more criteria

Locations (2)

Silver Hill Hospital

New Canaan, Connecticut, United States

NYU Langone Health

New York, New York, United States

Key Dates

Start Date

August 26, 2025

Primary Completion Date

May 1, 2029

Completion Date

May 1, 2029

Last Updated

December 19, 2025

Enrollment

200

ESTIMATED participants

Conditions

Alcohol Use Disorder

Interventions

Psilocybin

DRUG

Inactive Placebo

OTHER

Supportive therapy sessions

BEHAVIORAL

Contacts

Michael Bogenschutz, MD

CONTACT

646-501-4026 Michael.bogenschutz@nyulangone.org

Gillian Monty

CONTACT

646-754-3440 gillian.monty@nyulangone.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD

Inclusion Criteria

Exclusion Criteria

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