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Search / Trial NCT05403086

Pragmatic Trial of Psilocybin Therapy in Palliative Care

Launched by CHARLES S. GROB, M.D. · Jun 1, 2022

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Palliative Care Serious Medical Illness Life Threatening Condition Advanced And Progressive Illness

ClinConnect Summary

This clinical trial is studying the use of psilocybin therapy to help adults who are feeling demoralized due to life-threatening illnesses, particularly those who are nearing the end of life. Demoralization is a state of feeling hopeless and helpless, which can significantly affect a person's quality of life. The trial aims to see if psilocybin, a naturally occurring compound found in certain mushrooms, can improve mood and overall well-being in patients with a life expectancy of two years or less.

To participate in the trial, individuals must be between the ages of 65 and 74, have a serious illness with a limited life expectancy, and experience moderate to severe demoralization. They should also be able to take oral medications. Participants in the study will receive either psilocybin therapy or an active control treatment, and the study involves multiple visits for assessments. Importantly, participants will be closely monitored to ensure their safety throughout the trial. This study is currently recruiting participants, and anyone interested should discuss their eligibility with their healthcare provider.

Gender

ALL

Eligibility 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

About Charles S. Grob, M.D.

Charles S. Grob, M.D., is a distinguished clinical researcher and psychiatrist with extensive experience in the field of psychopharmacology and psychedelic research. As a pioneer in the investigation of novel therapeutic approaches for mental health disorders, Dr. Grob has contributed significantly to the understanding of the safety and efficacy of psychedelic substances in clinical settings. His work is characterized by a commitment to rigorous scientific methodology and ethical standards, aimed at advancing innovative treatment options for conditions such as depression, anxiety, and PTSD. Dr. Grob's leadership in clinical trials reflects a dedication to enhancing patient care through evidence-based research and collaboration within the medical community.

Locations

Torrance, California, United States

Rockville, Maryland, United States

San Francisco, California, United States

Patients applied

0 patients applied

Trial Officials

Charles S. Grob, M.D.

Principal Investigator

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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