Pragmatic Trial of Psilocybin Therapy in Palliative Care
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.
100 participants
Jan 19, 2025
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria7
- 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 Criteria30
- 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
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Interventions
Psilocybin, \[3-\[2-(dimethylamino)ethyl\]-1H-indol-4-yl\] dihydrogen phosphate.
ketamine hydrochloride injection, for intravenous or intramuscular use, contains ketamine, a nonbarbiturate general anesthetic and has a molecular formula of C13H16ClNO•HCl and a molecular weight of 274.19. The chemical name for ketamine hydrochloride is (±)-2-(o-Chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride.
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05403086