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RECRUITING
NCT05403086
PHASE2

Pragmatic Trial of Psilocybin Therapy in Palliative Care

Sponsor: Charles S. Grob, M.D.

View on ClinicalTrials.gov

Summary

This multicenter, triple-blind, phase 2, randomized controlled trial will evaluate the efficacy and safety of psilocybin therapy compared to an active control in treating demoralization in adults near the end of life (≤2 years life expectancy).

Official title: Pragmatic Trial of Psilocybin Therapy in Palliative Care (PT2PC): A Multicenter Triple-blind Phase 2 Randomized Controlled Trial of Psilocybin Therapy for Demoralized Adults Near the End of Life

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-01-19

Completion Date

2027-12-31

Last Updated

2025-11-25

Healthy Volunteers

No

Conditions

Interventions

DRUG

Psilocybin

Psilocybin, \[3-\[2-(dimethylamino)ethyl\]-1H-indol-4-yl\] dihydrogen phosphate.

DRUG

Ketamine

ketamine hydrochloride injection, for intravenous or intramuscular use, contains ketamine, a nonbarbiturate general anesthetic and has a molecular formula of C13H16ClNO•HCl and a molecular weight of 274.19. The chemical name for ketamine hydrochloride is (±)-2-(o-Chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride.

Locations (5)

Marin Cancer Care

Greenbrae, California, United States

University of California, Los Angeles

Los Angeles, California, United States

University of San Francisco

San Francisco, California, United States

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, United States

Sunstone Therapies

Rockville, Maryland, United States