drugset / Trial / NCT06827054

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

NCT06827054

Phase 2 Not yet recruiting 20 enrolled Roswell Park Cancer Institute
NaSingle-groupOpen-labelSupportive care

Summary

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.

Timeline

Start
2026-08-15
Primary completion
2027-05-05
Completion
2027-05-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Psilocybin Other / unclassified Oral