Psilocybin With Psychotherapy for Improving Chronic Pain in Cancer Patients Requiring Opioids

This Phase II trial (n=20) will study the safety, tolerability, and effectiveness of low-dose psilocybin therapy combined with psychotherapy for managing chronic pain in cancer patients who require opioids. Participants will receive psilocybin twice weekly for four weeks (8 doses total) alongside preparatory and integration psychotherapy sessions.

The study, sponsored by Roswell Park Cancer Institute, aims to assess whether psilocybin can reduce pain levels, decrease opioid dependence, and improve psychological well-being in cancer patients.

Researchers will also explore psilocybin’s potential mechanisms of action, including its effects on brain activity, inflammation, and psychological processes. Functional MRI (fMRI) scans and biomarker collection will be used to evaluate these changes. Patients will be followed up at multiple time points after completing the intervention. The trial is expected to run from March 2025 to March 2027 in Buffalo, New York.

Topic Palliative Care Pain Safety
Compound Psilocybin
Country United States of America
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