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New treatment option for Demoralization
Official title Pragmatic Trial of Psilocybin Therapy in Palliative Care
ClinicalTrials.gov ID: NCT05403086
What this study is testing
What is Psilocybin?
Psilocybin is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for demoralization.
Also referred to as Hallucinogen.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Greenbrae, California, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Torrance, California, United States
- Rockville, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Greenbrae, California, United States; Los Angeles, California, United States; San Francisco, California, United States; Torrance, California, United States; Rockville, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.