Psilocybin for Opioid Use Disorder (OUD)

This double-blind, adaptive, two-stage, multi-site, Phase II randomised controlled trial (n=240) will evaluate the effects of moderate and high-dose psilocybin (20-30mg), relative to a low-dose control (1mg), in patients with opioid use disorder (OUD) who continue to use illicit opioids despite adherence to methadone treatment.

Sponsored by NYU Langone Health, the study aims to assess the safety and efficacy of psilocybin as an adjunctive treatment for OUD. Participants will be randomly assigned to receive a single oral dose of either 30 mg (high dose), 20 mg (medium dose), or 1 mg (control condition). An interim statistical analysis will determine whether the study proceeds to Stage 2, retaining only the most effective active dose(s).

The primary outcomes include safety assessments and opioid abstinence, measured through biologically verified markers over 24 weeks. Secondary objectives involve evaluating psilocybin’s impact on OUD-related neuropsychopathology and identifying predictors of treatment response using machine learning. The trial will take place across multiple sites in New York and New Mexico, with an estimated completion date of September 2029.

Topic Opioid Use Disorder Addiction
Compound Psilocybin
Country United States of America
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Trial Details



Trial Number

Sponsors & Collaborators

NYU Langone Health
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National Institute on Drug Abuse
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Data attribution

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