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Low-Dose Psilocybin Therapy for Palliative Care Patients With Chronic Cancer Pain Requiring Opioids

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.

Status
planned
Phase
Phase 2
Institution
Roswell Park Cancer Institute
Principal investigator
William Alexander
Start date
2026-08-15
End date
2027-05-05
Registry ID
NCT06827054

View trial record

Tracked by the DMT Code Clinical Trials Observatory, an open record of DMT-related clinical research.