Pragmatic Trial of Psilocybin Therapy in Palliative Care (PT2PC)

This multicenter, triple-blind, Phase II, 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).

Status Not yet recruiting
Results Published
Start date 01 October 2022
End date 26 December 2026
Design Blinded
Type Interventional
Generation First
Participants 100
Sex All
Age 18- 99
Therapy No

Trial Details

After providing written informed consent, participants deemed eligible for this trial will be randomized to a brief course of talk therapy plus 1 dose of oral psilocybin vs the same brief course of talk therapy plus 1 dose of oral ketamine (the active control). Participants' degree of demoralization and other clinical outcomes (e.g., depression, anxiety) will be assessed at 1, 2, and 5 weeks after the study drug administration. After completing the study, participants will have the option of being told which study drug they took (aka, "unblinded"); those who were randomized to the active control will be offered another brief course of talk therapy plus 1 dose of oral psilocybin, and the same sequence of outcome assessments.

Trial Number NCT05403086

Sponsors & Collaborators

University of California San Francisco
At UCSF, there are two research teams dedicated to the study of psychedelics; the Neuroscape Psychedelic Division and the Translational Psychedelic Research Program.

Data attribution

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