Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD
Status:
NOT_YET_RECRUITING
Trial end date:
2029-05-01
Target enrollment:
Participant gender:
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.
Phase:
PHASE2
Details
Lead Sponsor:
NYU Langone Health
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)