Pragmatic Trial of Psilocybin Therapy in Palliative Care
ConditionDemoralization
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCharles S. Grob, M.D.
About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
Known allergic or severe reactions to the non-psychoactive components of psilocybin capsules or liquid ketamine
Treatment with another investigational drug or intervention within 1 month of signing Informed Consent Form (ICF)
If deemed by clinical judgment of the study investigators to be unsafe for undergoing the intervention
Cognitive impairment sufficient to impede the ability to complete study tasks
Trial design
Treatments tested in this trial
- Psilocybin
- Ketamine
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Charles S. Grob, M.D.
Lead sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Sponsor institution
University of California, San Francisco
Collaborator
Source ClinicalTrials.gov