Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD
This double-blind, randomized, placebo-controlled Phase II trial (n=200) investigates the therapeutic neural mechanisms of psilocybin (30mg) in patients with alcohol use disorder (AUD).
Details
Randomized, double-blind, placebo-controlled Phase II mechanistic trial of a single 30 mg oral dose of psilocybin versus matching placebo in 200 participants with moderate or severe alcohol use disorder receiving three manual-based supportive therapy sessions.
Primary measures include fMRI activation and functional connectivity to affective and alcohol-related stimuli, alcohol use (self-report and blood biomarkers), and self-report measures across negative emotionality, incentive salience, and executive function domains.
Participants are recruited from Silver Hill Hospital programs and must be in residential or inpatient care with specified recent heavy drinking, medical and MRI safety, and psychiatric exclusion criteria including psychosis, recent suicide attempts, and certain substance use histories.