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 FoundationIn 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.