Pragmatic Trial of Psilocybin Therapy in Palliative Care

Description

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).

Conditions

Demoralization

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Study Overview

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Study Details

Study overview

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).

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

Pragmatic Trial of Psilocybin Therapy in Palliative Care

Condition
Demoralization
Intervention / Treatment

-

Contacts and Locations

San Francisco

University of San Francisco, San Francisco, California, United States, 94518

Torrance

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, California, United States, 90502

Rockville

Sunstone Therapies, Rockville, Maryland, United States, 20850

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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)
  • * 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
  • * 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
  • * Uncontrolled hypertension
  • * Clinically significant cardiac disease
  • * Severe pulmonary disease
  • * Supplemental oxygen requirement
  • * Current intractable nausea/vomiting/diarrhea
  • * Recent, clinically significant GI bleed
  • * Markedly abnormal liver function tests
  • * Pregnancy or lactation
  • * Severe renal insufficiency
  • * Unstable insulin-dependent diabetes mellitus
  • * Antipsychotics (with exceptions)
  • * Antidepressants (with exceptions)
  • * Dopamine agonists
  • * Drugs known to have adverse interactions with psilocybin or ketamine

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Charles S. Grob, M.D.,

Charles S. Grob, M.D., PRINCIPAL_INVESTIGATOR, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Study Record Dates

2027-12-31