This open-label, single-group assignment trial (n=15) aims to assess the feasibility, safety, and preliminary efficacy of psilocybin-assisted therapy for opioid-refractory pain in patients with advanced cancer.
Psilocybin, a tryptamine derivative, will be administered to participants in a novel palliative-care informed psychotherapy regimen. The study, sponsored by Yvan Beaussant, MD, MSci, with support from Filament Health, Cy Biopharma, and Pancreatic Cancer North America, is conducted at Dana-Farber Cancer Institute, Brigham and Women’s Hospital, and Massachusetts General Hospital in Boston, Massachusetts, United States.
Participants, aged 18 years and older, with advanced cancer and opioid-refractory pain, will undergo screening for eligibility, including assessments such as electrocardiogram and blood tests. The intervention consists of preparation sessions, one psilocybin session, integration sessions, and follow-up visits over a 12-week period.
Feasibility and acceptability of the intervention will be measured, along with changes in pain intensity, interference, catastrophizing, and oral morphine equivalent from baseline. Exclusion criteria include certain medical conditions, concurrent treatments, and medications with potential interactions. The study, with the ClinicalTrials.gov ID NCT06001749, started in January 2024 and is estimated to be completed by December 2026.
Trial Details
The overall objective of this study is to assess the feasibility, safety and preliminary efficacy of psilocybin-assisted therapy to alleviate opioid-refractory pain in patients with advanced-cancer.NCT Number NCT06001749