NCT04950608

Pilot Study of Psilocybin-Assisted Therapy for Demoralization in Patients Receiving Hospice Care

Pilot Study of Psilocybin-Assisted Therapy for Demoralization in Patients Receiving Hospice Care - PATH Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Yvan Beaussant, MD, MSci · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Hospice
• Psilocybin
• Demoralization
• Terminal Illness
• Cancer-related Problem/Condition
• Psychotherapy
• Terminal Cancer
• Cancer Terminal

Interventions

Type	Name	Description
DRUG	Psilocybin	Oral, single administration, dosage 25 mg orally
BEHAVIORAL	Psychotherapy	The treatment regimen consists of a single administration of psilocybin orally combined with a supportive psychotherapy including 2 preparation sessions and 2 integration sessions

Timeline

• Start date: 2022-03-09
• Primary completion: 2024-07-27
• Completion: 2025-12-31
• First posted: 2021-07-06
• Last updated: 2026-02-17
• Results posted: 2025-09-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study