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
Chance of happening 85%
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.

NCT 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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