Status:
RECRUITING
Pragmatic Trial of Psilocybin Therapy in Palliative Care
Lead Sponsor:
Charles S. Grob, M.D.
Collaborating Sponsors:
University of California, San Francisco
Conditions:
Demoralization
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed 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 ta...
Eligibility Criteria
Inclusion
- 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
- General
- 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
- Neurological
- Cognitive impairment sufficient to impede the ability to complete study tasks
- History of intracranial hemorrhage
- Recent embolic stroke
- Recent seizure
- Current intracranial mass
- Advanced stage of a neurologic disease that elevates risk for psychosis
- Cardiovascular
- Uncontrolled hypertension
- Clinically significant cardiac disease
- Respiratory
- Severe pulmonary disease
- Supplemental oxygen requirement
- Gastrointestinal
- Current intractable nausea/vomiting/diarrhea
- Recent, clinically significant GI bleed
- Markedly abnormal liver function tests
- Endocrine, Renal, and Reproductive
- Pregnancy or lactation
- Severe renal insufficiency
- Unstable insulin-dependent diabetes mellitus
- Prohibited Medications
- Antipsychotics (with exceptions)
- Antidepressants (with exceptions)
- Dopamine agonists
- Drugs known to have adverse interactions with psilocybin or ketamine
Key Trial Info
Start Date :
January 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05403086
Start Date
January 19 2025
End Date
December 31 2027
Last Update
November 25 2025
Active Locations (5)
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1
Marin Cancer Care
Greenbrae, California, United States, 94904
2
University of California, Los Angeles
Los Angeles, California, United States, 90095
3
University of San Francisco
San Francisco, California, United States, 94518
4
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States, 90502