RecruitingPhase 2NCT06349083

Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD

Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for Alcohol Use Disorder

Sponsor

NYU Langone Health

Enrollment

200 participants

Start Date

Aug 26, 2025

Study Type

INTERVENTIONAL

Conditions

Alcohol Use Disorder

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Inactive Placebo, a drug called Psilocybin, and others for people with alcohol use disorder. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPsilocybin

One 25 mg capsule and one 5 mg capsule (30 mg total) administered once orally

OTHERInactive Placebo

Two matching placebo capsules administered once orally

BEHAVIORALSupportive therapy sessions

Participants will receive three supportive therapy sessions of manual-based treatment from a Center for Psychedelic Medicine (CPM) clinician, accompanied by a Silver Hill Hospital (SHH) therapist who has an ongoing therapeutic relationship with the participant. The CPM clinician will be a licensed physician, clinical psychologist, or nurse practitioner who will be solely responsible for the content of the intervention. The SHH therapist will provide additional support and continuity with clinical treatment.