NCT06644170

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

A Phase 1 Study of a Second Psilocybin Group Retreat for Partial Responders With Anxiety Associated With Metastatic Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OUTLINE: Patients receive psilocybin orally (PO) with optional booster dose on day 0. Patients attend an individual prep visit on day -1 and an individual integration visit on day 1. Patients also attend group preparation visits on days -14, -7 and -1 and group integration visits on days 1, 8, 22 and 36. After completion of study treatment, patients are followed up at 2, 3, and 6 months.

Conditions

• Hematopoietic and Lymphatic System Neoplasm
• Metastatic Malignant Solid Neoplasm

Interventions

Type	Name	Description
BEHAVIORAL	Behavioral Intervention	Attend individual visits
BEHAVIORAL	Group Therapy	Attend group visits
DRUG	Psilocybin	Given PO
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2024-11-19
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2024-10-16
• Last updated: 2025-10-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study