NCT05847686

Psilocybin-Assisted Therapy for the Treatment of Cancer-Related Anxiety in Patients With Metastatic Cancer

A Phase 1/2 Study of a Group Model of Psilocybin-Assisted Therapy for Cancer-Related Anxiety in Patients With Metastatic Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This phase I/II trial tests the safety and side effects of psilocybin in combination with therapy for the treatment of patients with metastatic cancer and symptoms of anxiety and/or depression. Psilocybin is a substance being studied in conjunction with therapy for the treatment of anxiety and depression in patients with cancer. In this study, the psilocybin being used is derived from the mushroom psilocybe cubensis using a patented process that results in a pharmaceutical grade version of psilocybin. Psilocybin acts by activating serotonin receptors on brain cells which can change perceptions and patterns of thinking in ways that may decrease anxiety.

Detailed description

OUTLINE: Patients receive psilocybin orally (PO) and participate in group and individual therapy sessions on trial.

Conditions

• Hematopoietic and Lymphatic System Neoplasm
• Metastatic Malignant Solid Neoplasm

Interventions

Type	Name	Description
OTHER	Counseling	Participate in therapy visits
DRUG	Psilocybin	Given PO
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2023-06-27
• Primary completion: 2024-04-08
• Completion: 2024-10-17
• First posted: 2023-05-08
• Last updated: 2025-11-05
• Results posted: 2025-04-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study