Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for Alcohol Use Disorder
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.
- Status
- recruiting
- Phase
- Phase 2
- Institution
- NYU Langone Health
- Principal investigator
- Michael Bogenschutz, MD
- Start date
- 2025-08-26
- End date
- 2030-05-01
- Registry ID
- NCT06349083
Tracked by the DMT Code Clinical Trials Observatory, an open record of DMT-related clinical research.