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
Charles S. Grob, M.D.
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).
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 contr…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: General * Provision of signed and dated informed consent form and the capacity to consent to research. * Stated willingness to comply with all study procedures and availability for the duration of the study * Is currently a patient in a study-engaged clinical site * Has a life-threatening illness and a life expectancy of ≤2 years * Has moderate-to-severe demoralization * Ability to take oral medication (capsules and liquid) Exclusion Criteria: General * Known allergic or severe reactions to the non-psychoactive components of psilocybin capsules or liquid ketamine * Tre…