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).
Topic Anxiety
Depression
Compound Psilocybin
Ketamine
Country United States of America
Visit trial
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 FranciscoAt UCSF, there are two research teams dedicated to the study of psychedelics; the Neuroscape Psychedelic Division and the Translational Psychedelic Research Program.