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).

Led by NYU Langone Health, the study aims to assess the effects of psilocybin on AUD through fMRI neural activation, alcohol use data, and self-report measures related to neural, emotional, and executive functions. Participants, aged 18 to 65, with a breath alcohol concentration ≤ 0.01%, will undergo either a single session of oral high-dose psilocybin (30 mg) or placebo, accompanied by three supportive therapy sessions.

Primary outcome measures include changes in the alcohol cue-induced BOLD signal in various brain regions, while secondary outcomes involve alcohol consumption patterns.

The study, scheduled from July 2024 to January 2029, aims to determine the potential of psilocybin-assisted treatment for AUD.

Topic Alcohol Use Disorder Addiction
Compound Psilocybin Placebo
Country United States of America
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 July 2024
End date 31 January 2029
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 200
Sex All
Age 18- 65
Therapy Yes

Trial Details

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.

NCT Number NCT06349083

Sponsors & Collaborators

NYU Langone Health
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Data attribution

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