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).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05403086.
Locations matching your search criteria
United States
California
San Francisco
University of California San FranciscoStatus: Active
Name Not Available
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.
Lead OrganizationCharles S. Grob, M.D.
Principal InvestigatorCharles S. Grob
