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

This phase I/II trial (n=56) will study the safety and side effects of psilocybin in combination with therapy for treating cancer-related anxiety in patients with metastatic cancer. Psilocybin is being studied to treat anxiety or depression in patients with advanced cancer. Participants will receive psilocybin orally and participate in group and individual therapy sessions.

Topic Anxiety Palliative Care
Compound Psilocybin
Country United States of America
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 September 2023
End date 01 December 2024
Chance of happening 100%
Phase Phase I Phase II
Design Blinded
Type Interventional
Generation First
Participants 56
Sex All
Age 18- 80
Therapy Yes

Trial Details

This phase I/II trial tests the safety and side effects of psilocybin in combination with therapy for the treatment of patients with cancer for which no treatment is currently available. Psilocybin is a substance being studied for the treatment of anxiety or depression in patients with advanced cancer. It is taken from the mushroom psilocybe mexicana. Psilocybin acts on the brain to cause hallucinations (sights, sounds, smells, tastes, or touches that a person believes to be real but are not real). Giving psilocybin in combination with therapy may decrease anxiety in patients with metastatic cancer.

NCT Number NCT05847686

Sponsors & Collaborators

Steven and Alexandra Cohen Foundation
In the bustling neighbourhood of Washington Heights, New York, Alexandra Cohen learned the true value of community and the importance of giving back. From her mother's acts of kindness to the neighbours, she understood that change starts with one person. Today, that core belief drives the Steven & Alexandra Cohen Foundation's philanthropic endeavours across the United States.

Washington University School of Medicine
Located in St. Louis Missouri, researchers at the Washington University School of Medicine have conducted a number of studies with psychedelics inlcuding ketamine, psilocybin and nitrous oxide.

Papers

Evolving Guidelines for the Use of Touch During a Clinical Trial of Group Psilocybin-Assisted Therapy
This technical report (2024) describes the evolving guidelines for facilitator use of touch in a group retreat-based format of psilocybin-assisted therapy. The primary goal is to create a safe and supportive haptic experience during sessions, with a secondary goal of maintaining therapeutic boundaries and responding to participant experiences with empathy.

Data attribution

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