NCT05403086 · Charles S. Grob, M.D.
Pragmatic Trial of Psilocybin Therapy in Palliative Care
(PT2PC)
What this study is about
This conducted at multiple hospitals, triple-blind, phase 2, randomly assigned controlled trial will evaluate the effectiveness and safety of psilocybin therapy compared to an active control in treating demoralization in adults near the end of life (≤2 years life expectancy).
View original scientific 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).
Interventions
DRUG
Psilocybin
Psilocybin, \[3-\[2-(dimethylamino)ethyl\]-1H-indol-4-yl\] dihydrogen phosphate.
DRUG
Ketamine
ketamine hydrochloride injection, for intravenous or intramuscular use, contains ketamine, a nonbarbiturate general anesthetic and has a molecular formula of C13H16ClNO•HCl and a molecular weight of 274.19. The chemical name for ketamine hydrochloride is (±)-2-(o-Chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride.
Primary outcome measures
Change in patient-reported Demoralization Scale-II..
Time frame: From Pre-dose V4 to ~14-days post drug (V8), and from Pre-dose (V4) to ~35-days post drug (V9), compared to active control.
The DS-II is a validated, patient-reported outcome assessing demoralization with a 2-week recall period.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion 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)
Exclusion criteria
- 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
Where
- Greenbrae, California
- Los Angeles, California
- San Francisco, California
- Torrance, California
- Rockville, Maryland
Collaborators
University of California, San Francisco
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 25, 2025 · Source of record for eligibility and locations