NCT06001749

Psilocybin in Cancer Pain Study

Feasibility Phase 2 Study of Psilocybin-Assisted Therapy for Opioid-Refractory Pain in Patients With Advanced Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Yvan Beaussant, MD, MSci · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

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.

Conditions

• Opioid-Related Disorders
• Pain Management
• Pain Management and Care
• Advanced Cancer
• Advanced Cancers

Interventions

Type	Name	Description
DRUG	Psilocybin	A tryptamine derivative, capsule, taken orally.

Timeline

• Start date: 2024-09-23
• Primary completion: 2026-07-01
• Completion: 2026-12-31
• First posted: 2023-08-21
• Last updated: 2025-12-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study