Pragmatic Trial of Psilocybin Therapy in Palliative Care

a study on Demoralization End of Life Psilocybin Ketamine

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

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).

Official Title

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

Details

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 talk therapy plus 1 dose of oral ketamine (the active control). Participants' degree of demoralization and other clinical outcomes (e.g., depression, anxiety) will be assessed at 1, 2, and 5 weeks after the study drug administration. After completing the study, participants will have the option of being told which study drug they took (aka, "unblinded"); those who were randomized to the active control will be offered another brief course of talk therapy plus 1 dose of oral psilocybin, and the same sequence of outcome assessments.

Keywords

Demoralization, Palliative Care, Serious Medical Illness, Life-threatening Condition, Advanced and Progressive Illness, Ketamine, Psilocybin, Hallucinogens

Eligibility

You can join if…

Open to people ages 18 years and up

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 CAN'T join 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

Respiratory

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

Locations

  • University of San Francisco accepting new patients
    San Francisco California 94518 United States
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center accepting new patients
    Torrance California 90502 United States
  • Sunstone Therapies accepting new patients
    Rockville Maryland 20850 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Charles S. Grob, M.D.
ID
NCT05403086
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 100 study participants
Last Updated
Contact us about this trial