Summary

Eligibility
for people ages 18 years and up (full criteria)
Dates
study started
estimated completion

Description

Summary

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).

Official Title

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

Details

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.

Keywords

Demoralization Palliative Care Serious Medical Illness Life-threatening Condition Advanced and Progressive Illness Ketamine Psilocybin Hallucinogens

Eligibility

You can join if…

Open to people ages 18 years and up

  • Aged 18 years and older
  • Has the capacity to consent to research
  • 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)

You CAN'T join if...

General

  • 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

Psychiatric

  • Personal or family history of a primary psychotic disorder or primary bipolar disorder
  • Recent, clinically significant suicidal ideation

Cardiovascular

  • Uncontrolled hypertension
  • Clinically significant cardiac disease

Respiratory

Gastrointestinal

  • Current intractable nausea/vomiting/diarrhea
  • Recent, clinically significant GI bleed
  • Markedly abnormal liver function tests

Endocrine, Renal, and Reproductive

Prohibited Medications

  • Antipsychotics
  • Antidepressants (with exceptions)
  • Dopamine agonists
  • Drugs known to have adverse interactions with psilocybin or ketamine
  • Recent use of psychedelics or ketamine

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Charles S. Grob, M.D.
ID
NCT05403086
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 100 study participants
Last Updated