Actively Recruiting
Pragmatic Trial of Psilocybin Therapy in Palliative Care
Led by Charles S. Grob, M.D. · Updated on 2025-11-25
100
Participants Needed
5
Research Sites
153 weeks
Total Duration
On this page
Sponsors
C
Charles S. Grob, M.D.
Lead Sponsor
U
University of California, San Francisco
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Pragmatic Trial of Psilocybin Therapy in Palliative Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and capacity to consent to research
- Willingness to comply with all study procedures and availability for study duration
- Currently a patient at a study-engaged clinical site
- Has a life-threatening illness with life expectancy of 2 years or less
- Has moderate-to-severe demoralization
- Ability to take oral medication (capsules and liquid)
You will not qualify if you...
- Known allergy or severe reaction to non-psychoactive components of psilocybin capsules or liquid ketamine
- Treatment with another investigational drug or intervention within 1 month before consent
- Deemed unsafe for intervention by clinical judgment
- Cognitive impairment preventing completion of study tasks
- History of intracranial hemorrhage
- Recent embolic stroke
- Recent seizure
- Current intracranial mass
- Advanced neurologic disease increasing psychosis risk
- Uncontrolled hypertension
- Significant cardiac disease
- Severe pulmonary disease
- Need for supplemental oxygen
- Current intractable nausea, vomiting, or diarrhea
- Recent significant gastrointestinal bleed
- Markedly abnormal liver function tests
- Pregnancy or lactation
- Severe renal insufficiency
- Unstable insulin-dependent diabetes mellitus
- Use of antipsychotics (with exceptions)
- Use of antidepressants (with exceptions)
- Use of dopamine agonists
- Use of drugs with known adverse interactions with psilocybin or ketamine
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Marin Cancer Care
Greenbrae, California, United States, 94904
Actively Recruiting
2
University of California, Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
3
University of San Francisco
San Francisco, California, United States, 94518
Actively Recruiting
4
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States, 90502
Actively Recruiting
5
Sunstone Therapies
Rockville, Maryland, United States, 20850
Actively Recruiting
Research Team
C
Charles S. Grob, M.D.
CONTACT
B
Brian T Anderson, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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