Actively Recruiting
Phase 2 Trial of Psilocybin-Assisted Therapy for Opioid-Resistant Pain in Advanced Cancer Patients
Led by Yvan Beaussant, MD, MSci · Updated on 2026-08-05
15
Participants Needed
1
Research Sites
13 weeks
Total Duration
AI-Summary
What this Trial Is About
This research investigates psilocybin-assisted therapy as a potential treatment to relieve opioid-resistant pain in adults with advanced cancer. The study is a phase 2, open-label trial focusing on the feasibility, safety, and early effectiveness of this novel approach, which targets the serotonin system in the brain related to mood and motivation. Psilocybin is an investigational drug not yet FDA-approved but permitted for use in this research. Participants will receive a structured psilocybin-assisted psychotherapy regimen including preparation sessions, one in-clinic psilocybin dosing session, and multiple integration and follow-up visits. The treatment involves oral capsules of psilocybin administered once, followed by support sessions conducted both in-clinic and remotely over several weeks. The study is supported by Filament Health, Cy Biopharma, and Pancreatic Cancer North America. Throughout approximately 12 weeks of follow-up, participants will have various assessments including blood tests, electrocardiograms, pain intensity and interference questionnaires, and monitoring of opioid use. Researchers will evaluate therapy feasibility, acceptability, and changes in pain and opioid consumption. Participants will be supported by therapists during preparation, treatment, and integration phases, ensuring safety and adherence to study procedures.
CONDITIONS
Brief Title
Psilocybin in Cancer Pain Study
Research Team
A
Amani Ingram
I
Isabel Kristan
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