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

StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Start date: Aug 15, 2026 to Sep 15, 2026v10
  2. Notable Start date: May 15, 2026 to Aug 15, 2026v9
  3. Notable Start date: Mar 15, 2026 to May 15, 2026v8
  4. Minor Start date: Feb 15, 2026 to Mar 15, 2026v7
  5. Notable Primary completion date: May 5, 2026 to May 5, 2027
    • Start date: Nov 15, 2025 to Feb 15, 2026
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Notable Start date: Sep 15, 2025 to Nov 15, 2025v5
  2. Notable Start date: Jul 3, 2025 to Sep 15, 2025v4
  3. Notable Start date: May 3, 2025 to Jul 3, 2025v3
  4. Notable Primary completion date: Mar 5, 2025 to May 5, 2026
    • Start date: Mar 3, 2025 to May 3, 2025
    • Study completion date: Mar 5, 2027 to May 5, 2027
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT06827054
Lead Sponsor Roswell Park Cancer Institute
Conditions
(from sponsor)
Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov