Psilocybin therapy for demoralization in palliative care patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, triple-blind, phase 2 trial evaluates the efficacy and safety of psilocybin therapy compared to ketamine in treating demoralization in adults with a life expectancy of two years or less. Eligible participants will receive a brief course of talk therapy along with either psilocybin or ketamine, and their levels of demoralization, depression, and anxiety will be assessed at multiple time points after treatment. The study aims to provide insights into the potential benefits of psilocybin in improving psychological well-being in patients facing serious medical conditions.

Why it matters

Who can join: the full rules

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

Where it's running

• Marin Cancer Care
  Greenbrae, California, United States Recruiting
• University of California, Los Angeles
  Los Angeles, California, United States Recruiting
• University of San Francisco
  San Francisco, California, United States Recruiting
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
  Torrance, California, United States Recruiting
• Sunstone Therapies
  Rockville, Maryland, United States Recruiting

Study contacts

• Principal investigator: Charles S. Grob, M.D. — Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
• Study coordinator: Charles S. Grob, M.D.
• Email: pt2pc@lundquist.org
• Phone: (626) 522-8615

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.