RECRUITING

Pragmatic Trial of Psilocybin Therapy in Palliative Care

Conditions

Demoralization Palliative Care Serious Medical Illness Life-threatening Condition Advanced and Progressive Illness

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

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

Quick Facts

Study Start:2025-01-19

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05403086

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Charles S. Grob, M.D.

CONTACT

(626) 522-8615

psilocybin@lundquist.org

Brian T Anderson, M.D.

CONTACT

(310) 961-2662

psilocybin@lundquist.org

Principal Investigator

Charles S. Grob, M.D.

PRINCIPAL_INVESTIGATOR

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Study Locations (Sites)

University of San Francisco

San Francisco, California, 94518

United States

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, 90502

United States

Sunstone Therapies

Rockville, Maryland, 20850

United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-19

Study Completion Date2027-12-31

Study Record Updates

Study Start Date2025-01-19

Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

Palliative Care
Serious Medical Illness
Life-threatening Condition
Advanced and Progressive Illness

Additional Relevant MeSH Terms

Demoralization