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.
Trial Details
This phase II trial studies whether psilocybin with psychotherapy is safe and if it works for improving chronic pain in cancer patients who require opioids to manage their pain. Psilocybin is taken from the mushroom Psilocybe mexicana. Psilocybin acts on the brain to cause hallucinations (sights, sounds, smells, tastes, or touches that a person believes to be real but are not real). This may impact a patient's "total pain", a view that accounts for the psychological, spiritual, and social factors that contribute to their experience of pain. Psychotherapy uses methods such as discussion, listening, and counseling to help patients change the way they react to environmental triggers that may cause a negative reaction. Giving psilocybin with psychotherapy may be safe and helpful for improving chronic pain in cancer patients who require opioids to manage their pain.Trial Number NCT06827054