Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06349083
Study type	Interventional
Source	NYU Langone Health
Contact	Michael Bogenschutz, MD
Phone	646-501-4026
Email	Michael.bogenschutz@nyulangone.org
Status	Not yet recruiting
Phase	Phase 2
Start date	July 2024
Completion date	January 2029

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