Pragmatic Trial of Psilocybin Therapy in Palliative Care

• Status: Not yet recruiting
• Trial end date: 2026-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charles S. Grob, M.D.
• Collaborator: University of California, San Francisco
• Treatments: Hallucinogens; Ketamine; Psilocybin

Criteria

Inclusion Criteria:

• Aged 18 years and older

• Has the capacity to consent to research

• 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

• 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

Psychiatric

• Personal or family history of a primary psychotic disorder or primary bipolar disorder

• Recent, clinically significant suicidal ideation

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

• Antidepressants (with exceptions)

• Dopamine agonists

• Drugs known to have adverse interactions with psilocybin or ketamine

• Recent use of psychedelics or ketamine