Pragmatic Trial of Psilocybin Therapy in Palliative Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-19

Study Completion Date

2027-12-31

Brief Summary

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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).

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Detailed Description

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After providing written informed consent, participants deemed eligible for this trial will be randomized to a brief course of talk therapy plus 1 dose of oral psilocybin vs the same brief course of talk therapy plus 1 dose of oral ketamine (the active control). Participants' degree of demoralization and other clinical outcomes (e.g., depression, anxiety) will be assessed at 1, 2, and 5 weeks after the study drug administration. After completing the study, participants will have the option of being told which study drug they took (aka, "unblinded"); those who were randomized to the active control will be offered another brief course of talk therapy plus 1 dose of oral psilocybin, and the same sequence of outcome assessments.

Conditions

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Demoralization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel with optional Crossover for the control arm

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

A Multicenter Triple-blind Phase 2 Randomized Controlled Trial.

Study Groups

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Psilocybin

A single moderate-to-high dose of oral psilocybin, plus 4-5 sessions of a brief, existential psychotherapy.

Group Type EXPERIMENTAL

Psilocybin

Intervention Type DRUG

Psilocybin, \[3-\[2-(dimethylamino)ethyl\]-1H-indol-4-yl\] dihydrogen phosphate.

Ketamine

A single low-to-moderate dose of oral liquid ketamine, plus 4-5 sessions of a brief, existential psychotherapy.

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

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.

Interventions

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Psilocybin

Psilocybin, \[3-\[2-(dimethylamino)ethyl\]-1H-indol-4-yl\] dihydrogen phosphate.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Hallucinogen Ketalar

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No