Psilocybin in the Treatment of Cocaine Use Disorder: A Randomized Clinical Trial
By
Peter S. Hendricks
Sara N. Lappan
Richard C. Shelton
Adrienne C. Lahti
Karen L. Cropsey
Matthew W. Johnson
Melissa Bradley
Otto Simonsson
Lori L. Davis
Daniel H. Grossman
Cynthia E. Ortiz
May 7, 2026
Clinical Scorecard: Evaluating Psilocybin as a Therapeutic Option for Cocaine Use Disorder: Results from a Randomized Clinical Study
At a Glance
Category Detail
Condition Cocaine Use Disorder (CUD)
Key Mechanisms Psilocybin's potential antiaddictive properties and effects on mental health.
Target Population Adults aged 25 years or older with a DSM-IV diagnosis of cocaine dependence.
Care Setting University medical research center with a randomized, quadruple-blind, active placebo-controlled design.
Key Highlights
Psilocybin showed promise in increasing cocaine abstinent days. Participants received manualized psychotherapy alongside psilocybin or placebo. Study aimed to assess the efficacy of psilocybin in treating cocaine dependence.
Guideline-Based Recommendations
Diagnosis
Use DSM-IV criteria for diagnosing cocaine dependence. Assess severity of dependence using the Severity of Dependence Scale.
Management
Implement manualized psychotherapy in conjunction with psilocybin treatment. Monitor participants for cocaine use through biochemically verified urine samples.
Monitoring & Follow-up
Conduct follow-up assessments at 90 days and 180 days post-treatment. Utilize the timeline followback technique for drug use assessment.
Risks
Exclude individuals with current psychiatric disorders or a history of psychotic disorders. Monitor for potential adverse effects of psilocybin.
Patient & Prescribing Data
Adults with cocaine dependence who desire to quit.
Single oral dose of psilocybin (25 mg per 70 kg) administered in a controlled setting.
Clinical Best Practices
Ensure informed consent and thorough screening for eligibility. Maintain blinding and allocation concealment throughout the study. Provide comprehensive psychotherapy support before and after psilocybin administration.
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