A Second Psilocybin Group Therapy for the Treatment of Cancer-Related Anxiety in Partial Responders With Metastatic Cancer

Summary

This phase I trial tests the safety and side effects of a second episode of psilocybin-assisted group therapy and how well it works in treating anxiety and distress in patients with cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and had a partial response to their first retreat. Up to 50% of patients with metastatic cancer have clinically significant anxiety and unaddressed anxiety and distress may add to the suffering caused by cancer itself. Psilocybin, a psychedelic drug, is made using an extract from the psilocybe mushroom, also known as "magic mushrooms". Psilocybin binds to serotonin receptors (natural body chemicals that control moods) on brain cells producing intense changes in mood, including anxiety. This may change perceptions and patterns of thinking in ways that may decrease anxiety. Group therapy may reduce stress and improve the well-being and quality of life of patients with metastatic cancer. A second episode of psilocybin-assisted group therapy may be safe, tolerable and or effective in treating anxiety and distress in partial responders with metastatic cancer.

Timeline

Start

2024-11-19

Primary completion

2025-09-30

Completion

2025-09-30

Drugs

Indications