Pragmatic Trial of Psilocybin Therapy in Palliative Care

About

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 the end of life (≤2 years life expectancy).

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 2

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

Inclusion Criteria:

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 Criteria:

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