The overall objective of this study is to develop and pilot test a novel regimen of psilocybin-assisted psychotherapy for demoralization in patients receiving hospice care.
The name of the study drug involved in this study is psilocybin.
Compound Psilocybin
Country United States of America
Visit trial
Status
Not yet recruiting
Results Published
Start date
11 November 2020
End date
31 December 2022
Chance of happening
89%
Phase
Phase II
Design
Open
Type
Interventional
Generation
First
Participants
15
Sex
All
Age
18- 88
Therapy
Yes
Trial Details
The purpose of this research is to understand how psilocybin-assisted therapy may be adapted in the context of hospice care, in order to test its safety in people with terminal illness who experience demoralization, and to study how well it works to lessen symptoms of psychological and existential distress. This research study involves a combined drug and psychotherapeutic (talk therapy) intervention. The research study procedures include screening for eligibility, and study intervention including preparation, evaluations, one psilocybin session and follow up visits. The treatment regimen consists of a single administration of psilocybin with a supportive psychotherapy including 2 preparation sessions and 2 integration sessions The name of the study drug involved in this study is Psilocybin. Psilocybin is a naturally occurring psychedelic drug produced by more than 200 species of mushrooms, which is manufactured for medical use to control potency and purity. Participants will be followed for up to 24 weeks (approximately 6 months) after the study treatment. It is expected that about 15 people will take part in this research study. This research study is a Feasibility Study, which mean it is the first time investigators are examining psilocybin-assisted therapy in the context of hospice care. Psilocybin is an "Investigational" drug, meaning that the study drug has not been approved by the U.S. Food and Drug Administration (FDA) as a treatment for any disease. However, the FDA has granted psilocybin the status of "breakthrough therapy" in the treatment of depression and the investigators have permission from the FDA to use this drug in this research study.NCT Number NCT04950608
Sponsors & Collaborators
Usona InstituteThe Usona Institute was founded by Bill Linton and Malynn Utzinger. Currently, 18 people are associated with it. The institute is a non-profit that sponsors psilocybin research (and is funded by sponsors/philanthropists).
Heffter Research Institute
The Heffter Research Institute has been advancing psychedelics (psilocybin) as medicines since 1993.
Riverstyx Foundation
The Riverstyx Foundation sponsors a variety of psychedelic researchers and conferences.
Council on Spiritual Practices
The Council on Spiritual Practices is a non-profit that promotes psychedelics research and spiritual development.
Harvard University
Harvard is working with Mass General and their team at the Center for the Neuroscience of Psychedelics. Harvard Law School recently launched their POPLAR initiative.