Pragmatic Trial of Psilocybin Therapy in Palliative Care — PT2PC  

Demoralization Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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).

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Demoralization

• NCT number: NCT05403086
• Study type: Interventional
• Source: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
• Contact: Charles S. Grob, M.D.
• Phone: (310) 961-2662
• Email: psilocybin@lundquist.org
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 15, 2024
• Completion date: March 31, 2026