Pragmatic Trial of Psilocybin Therapy in Palliative Care
Recruiting now · Phase 2
Conditions studied: Demoralization
In brief
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).
Key facts
- Study ID
- NCT05403086
- Run by
- Charles S. Grob, M.D.
- People needed
- 100
- Starts
- 2025-01-19
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2025-11-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Marin Cancer Care — Greenbrae, California, United States (enrolling)
- University of California, Los Angeles — Los Angeles, California, United States (enrolling)
- University of San Francisco — San Francisco, California, United States (enrolling)
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance, California, United States (enrolling)
- Sunstone Therapies — Rockville, Maryland, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.