Actively Recruiting
Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD
Led by NYU Langone Health · Updated on 2025-12-19
200
Participants Needed
2
Research Sites
192 weeks
Total Duration
On this page
Sponsors
N
NYU Langone Health
Lead Sponsor
N
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide voluntary informed consent
- Breath alcohol concentration (BrAC) 64 0.01% at screening and at specified study visits
- Able to read, speak, and understand English
- Aged 18 to 65 years inclusive at screening
- Diagnosed with moderate or severe Alcohol Use Disorder (AUD) using DSM-5 criteria
- Currently in treatment at Silver Hill Hospital (Residential or Inpatient with plan for Residential Treatment)
- Able and willing to adhere to all study requirements including visits, therapy sessions, and assessments
- At least 4 heavy drinking days (4+ drinks for women, 5+ drinks for men) in the 30 days before admission to Silver Hill Hospital
- Agree to refrain from non-prescribed psychotropic or illicit drug use as specified before dosing and assessments
- Agree to avoid non-prescription medications and supplements for at least 1 week before dosing 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 two locator contacts
You will not qualify if you...
- Pregnancy or lactation
- Medical conditions that make participation unsafe, including seizure disorder, significant liver impairment, cardiovascular disease, uncontrolled hypertension, resting heart rate over 100 bpm, serious ECG abnormalities, hyperthyroidism, insulin-dependent diabetes, or other conditions as judged by the investigator
- Psychiatric disorders including lifetime schizophrenia spectrum or psychotic disorders, current alcohol withdrawal with score >7, history of mania
- Active suicidal ideation with intent or recent significant suicide attempt within past 12 months
- Family history of schizophrenia, schizoaffective disorder, or bipolar disorder type 1
- History of hallucinogen use disorder or persisting perceptual disorder
- Use of classic psychedelics in past year or more than 25 lifetime uses
- Incarceration or pending legal action that could prevent participation
- Court-mandated to complete residential treatment at Silver Hill Hospital
- Unable or unwilling to discontinue prohibited medications or supplements prior to dosing
- Allergy or hypersensitivity to psilocybin or materials in investigational product
- Allergy or contraindication to medications used to treat acute symptoms during dosing
- Any condition likely to interfere with study adherence or safety with psilocybin or MRI scanning
- Inability to safely complete MRI sessions
- History of severe traumatic brain injury or recent moderate/severe mild traumatic brain injury as assessed
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Silver Hill Hospital
New Canaan, Connecticut, United States, 06840
Actively Recruiting
2
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
Research Team
M
Michael Bogenschutz, MD
CONTACT
G
Gillian Monty
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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