What is psilocybin studying for Alcohol Use Disorder?

Psilocybin is being studied to understand its effects on brain activity and drinking behavior in people with Alcohol Use Disorder. Researchers want to learn if psilocybin changes brain responses to alcohol and negative emotions and if these changes relate to improvements in symptoms. This trial is led by NYU Langone Health to explore these questions.

Who may be eligible for this Alcohol Use Disorder clinical trial?

Adults aged 18 to 65 with moderate or severe Alcohol Use Disorder who are in treatment at Silver Hill Hospital may be eligible. Participants must be able to attend all visits, swallow capsules, and agree to study requirements. Please review eligibility criteria for more details.

Is there any cost to participate in this Alcohol Use Disorder clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or lodging costs.

Actively Recruiting

Phase 2

Age: 18Years - 65Years

All Genders

ID06349083

Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for Alcohol Use Disorder

Led by NYU Langone Health · Updated on 2025-12-19

200

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the effects of psilocybin on people with moderate to severe Alcohol Use Disorder AUD in a Phase 2 clinical trial. This trial aims to understand how psilocybin affects brain activity related to alcohol use and negative emotions, and whether these changes relate to improvement in AUD symptoms. The study will measure brain responses using fMRI scans, alcohol consumption through self-reports and blood tests, and self-reported behavioral and emotional factors. Participants will be randomly assigned to receive either a single oral dose of psilocybin 30 mg total or matching placebo capsules. Both groups will also participate in three supportive therapy sessions conducted by specialized therapists. These sessions aim to support participants during the treatment process. The study is double-blinded, meaning neither participants nor researchers know who receives psilocybin or placebo. Throughout the study, participants will undergo brain imaging with fMRI before and after treatment to assess changes in brain activity. They will also provide blood samples and complete questionnaires related to alcohol use, mood, impulsivity, and quality of life over a 24-week period. Researchers will closely monitor safety and treatment effects, including alcohol drinking patterns and brain responses, to better understand the potential of psilocybin in treating AUD.

CONDITIONS

Brief Title

Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD

Who Can Participate

Age: 18Years - 65Years

All Genders

Eligibility Criteria

You may qualify if you...

Able to provide voluntary informed consent
Breath alcohol concentration (BrAC) ≤ 0.01% at screening
Able to read, speak, and understand English
Aged 18 to 65 years, inclusive
Diagnosed with moderate or severe Alcohol Use Disorder (DSM-5)
Currently in treatment at Silver Hill Hospital
Willing and able to attend all study visits and therapy sessions
At least 4 heavy drinking days in the 30 days before admission to SHH
Agree to avoid non-prescribed psychotropic substances and illicit drugs as specified
Agree to avoid non-prescription medications and supplements 1 week prior to treatment unless approved
Able to swallow capsules
Negative pregnancy test at screening, baseline, Day 0, and Day 2
Willing to use approved contraception if able to become pregnant or produce viable sperm
Able to provide at least 2 locators

You will not qualify if you...

Pregnancy or breastfeeding
Medical conditions that increase risk or prevent safe participation, including seizure disorder, significant liver impairment, cardiovascular disease, uncontrolled hypertension, resting heart rate > 100 bpm, serious ECG abnormalities, hyperthyroidism, insulin-dependent diabetes
Psychiatric disorders including schizophrenia spectrum, psychotic disorders, current alcohol withdrawal, history of mania
Active suicidal ideation with intent or recent medically significant suicide attempt
Family history of schizophrenia, schizoaffective disorder, or bipolar disorder type 1
History of hallucinogen use disorder or hallucinogen persisting perceptual disorder
Use of classic psychedelics in the past year or more than 25 lifetime uses
Incarcerated or pending legal action affecting participation
Court-mandated treatment at SHH
Unable or unwilling to discontinue prohibited medications or supplements
Allergy or hypersensitivity to psilocybin or study materials
Allergy or contraindication preventing safe treatment of acute hypertension, anxiety, or psychotic symptoms during the study
Conditions interfering with rapport, adherence, or safe administration of psilocybin or fMRI
Unable to safely complete fMRI sessions
History of severe traumatic brain injury or recent moderate/severe TBI with high symptom score as determined by the investigator

Research Team

Michael Bogenschutz, MD

Gillian Monty

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