NCT06349083

Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD

Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for Alcohol Use Disorder

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcohol Use Disorder

Interventions

Type	Name	Description
DRUG	Psilocybin	One 25 mg capsule and one 5 mg capsule (30 mg total) administered once orally
OTHER	Inactive Placebo	Two matching placebo capsules administered once orally
BEHAVIORAL	Supportive 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.

Timeline

• Start date: 2025-08-26
• Primary completion: 2029-05-01
• Completion: 2029-05-01
• First posted: 2024-04-05
• Last updated: 2025-12-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study