Advanced Cancer Clinical Trial
Official title:
Feasibility Phase 2 Study of Psilocybin-Assisted Therapy for Opioid-Refractory Pain in Patients With Advanced Cancer
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. The name of the study intervention used in this research study is: Psilocybin (a tryptamine derivative)
This study is a phase 2 open label, single center, concurrent mixed-methods trial to assess the feasibility of a novel palliative-care informed psilocybin-assisted psychotherapy regimen to alleviate opioid-refractory pain in patients with advanced-cancer. Psilocybin works on the serotonin system in the brain which is linked to the regulation of mood, motivation and impulse control. Psilocybin is an "Investigational" drug, meaning that the study drug has not been approved by the U.S. Food and Drug Administration (FDA) as a treatment for any disease. However, investigators have permission from the FDA to use this drug in this research study. The research study procedures include screening for eligibility, an electrocardiogram, blood tests, and the study intervention includes preparation, evaluations, one psilocybin session and follow up visits. Participants will be followed for up to 12 weeks (approximately 3 months) after receiving the study treatment. It is expected that about 15 people will take part in this research study. Filament Health is supporting this research study by providing the study investigational medication, psilocybin. Cy Biopharma and Pancreatic Cancer North America are supporting this research study by providing funding. ;
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