Psilocybin therapy for demoralization in palliative care patients
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
PHASE2 · Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center · NCT05403086
This study is testing if psilocybin therapy can help improve feelings of hopelessness in adults with serious illnesses who have a life expectancy of two years or less, compared to ketamine.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center (other) |
| Locations | 5 sites (Greenbrae, California and 4 other locations) |
| Trial ID | NCT05403086 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with a life-threatening illness and moderate-to-severe demoralization who can take oral medication.
Not a fit: Patients with cognitive impairments or those who have had recent neurological events may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve the quality of life and emotional well-being for patients nearing the end of life.
How similar studies have performed: Other studies have shown promising results with psilocybin and similar therapies, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Greenbrae, California and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Demoralization, Palliative Care, Serious Medical Illness, Life-threatening Condition, Advanced and Progressive Illness