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Pragmatic Trial of Psilocybin Therapy in Palliative Care (PT2PC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05403086
Recruitment Status : Not yet recruiting
First Posted : June 3, 2022
Last Update Posted : October 24, 2023
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Charles S. Grob, M.D., Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Brief 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).

Condition or disease Intervention/treatment Phase
Demoralization Drug: Psilocybin Drug: Ketamine Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel with optional Crossover for the control arm
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 14, 2024
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : March 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care
Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Psilocybin
A single moderate-to-high dose of oral psilocybin, plus 4-5 sessions of a brief, existential psychotherapy.
Drug: Psilocybin
Psilocybin, [3-[2-(dimethylamino)ethyl]-1H-indol-4-yl] dihydrogen phosphate.
Other Name: Hallucinogen

Active Comparator: Ketamine
A single low-to-moderate dose of oral liquid ketamine, plus 4-5 sessions of a brief, existential psychotherapy.
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.
Other Name: Ketalar




Primary Outcome Measures :
  1. Change from Baseline on 16-item Demoralization Scale - II (DS-II) at Week 5 [ Time Frame: Baseline and Week 5 ]
    The DS-II is a validated, patient-reported outcome assessing demoralization with a 2-week recall period. Possible scores range 0-32 with higher scores indicating a greater degree of demoralization.

  2. Change from Baseline on 16-item Demoralization Scale - II (DS-II) at Week 2 [ Time Frame: Baseline and Week 2 ]
    The DS-II is a validated, patient-reported outcome assessing demoralization with a 2-week recall period. Possible scores range 0-32 with higher scores indicating a greater degree of demoralization.


Secondary Outcome Measures :
  1. Odds of improvement from Baseline on Clinical Global Impression scale (CGI-I) for demoralization at Week 5. [ Time Frame: Baseline and Week 5 ]
    The CGI-I is a widely used and validated assessment of global clinical improvement. Possible scores range "0=Not assessed", "1=Very much improved", to "7=Very much worse." The CGI-I has been adapted here for assessing improvement in demoralization.

  2. Odds of improvement from Baseline on Clinical Global Impression scale (CGI-I) for demoralization at Week 2. [ Time Frame: Baseline and Week 2 ]
    The CGI-I is a widely used and validated clinician-rated assessment of global clinical improvement. Possible scores range "0=Not assessed", "1=Very much improved", to "7=Very much worse." The CGI-I has been adapted here for assessing improvement in demoralization.

  3. Odds of meeting criteria for demoralization on the Diagnostic Criteria for Psychosomatic Research-Revised (DCPR-R) at Week 5. [ Time Frame: Week 5 ]
    The DCPR-R is a validated clinician-rated assessment of various psychosomatic conditions, including demoralization, which is rated as Present or Absent with a 1-month recall period.

  4. Odds of meeting criteria for demoralization on the Diagnostic Criteria for Psychosomatic Research-Revised (DCPR-R) at Week 2. [ Time Frame: Week 2 ]
    The DCPR-R is a validated clinician-rated assessment of various psychosomatic conditions, including demoralization, which is rated as Present or Absent with a 1-month recall period.

  5. Change from Baseline on GRID Hamilton Rating Scale for Depression 6-item (GRID-HAMD-6) at Week 5. [ Time Frame: Baseline and Week 5 ]
    The GRID-HAMD-6 is a validated, clinician-rated measure of the core symptoms of major depression. Possible scores range 0-4 with higher scores indicating a greater degree of depressed mood.

  6. Change from Baseline on GRID Hamilton Rating Scale for Depression 6-item (GRID-HAMD-6) at Week 2. [ Time Frame: Baseline and Week 2 ]
    The GRID-HAMD-6 is a validated, clinician-rated measure of the core symptoms of major depression. Possible scores range 0-4 with higher scores indicating a greater degree of depressed mood.

  7. Change from Baseline on Patient Health Questionnaire-9 (PHQ-9) at Week 5. [ Time Frame: Baseline and Week 5 ]
    The PHQ-9 is a validated, patient-reported outcome assessing depression symptom severity with a 2-week recall period. Possible scores range 0-27 with higher scores indicating worse depression.

  8. Change from Baseline on Patient Health Questionnaire-9 (PHQ-9) at Week 2. [ Time Frame: Baseline and Week 2 ]
    The PHQ-9 is a validated, patient-reported outcome assessing depression symptom severity with a 2-week recall period. Possible scores range 0-27 with higher scores indicating worse depression.

  9. Change from Baseline on Generalized Anxiety Disorder-7 (GAD-7) at Week 5. [ Time Frame: Baseline and Week 5 ]
    The GAD-7 is a validated, patient-reported outcome assessing the severity of generalized anxiety disorder (GAD) symptoms with a 2-week recall period. Possible scores range 0-21 with higher scores indicating greater severity of symptoms of GAD.

  10. Change from Baseline on Generalized Anxiety Disorder-7 (GAD-7) at Week 2. [ Time Frame: Baseline and Week 2 ]
    The GAD-7 is a validated, patient-reported outcome assessing the severity of generalized anxiety disorder (GAD) symptoms with a 2-week recall period. Possible scores range 0-21 with higher scores indicating greater severity of symptoms of GAD.

  11. Change from Baseline on Functional Assessment of Chronic Illness Therapy-Palliative Care 14-item scale (FACIT-Pal-14) at Week 5. [ Time Frame: Baseline and Week 5 ]
    The FACIT-Pal-14 is a validated, patient-reported outcome assessing quality of life in palliative care patients with a 7-day recall period. Possible scores range 0-56 with higher scores indicating a better quality of life.

  12. Change from Baseline on Functional Assessment of Chronic Illness Therapy-Palliative Care 14-item scale (FACIT-Pal-14) at Week 2. [ Time Frame: Baseline and Week 2 ]
    The FACIT-Pal-14 is a validated, patient-reported outcome assessing quality of life in palliative care patients with a 7-day recall period. Possible scores range 0-56 with higher scores indicating a better quality of life.

  13. Change from Baseline on Functional Assessment of Chronic Illness Therapy-Spiritual Well-being 12-item scale (FACIT-Sp-12) at Week 5. [ Time Frame: Baseline and Week 5 ]
    The FACIT-Sp-12 is a validated, patient-reported outcome assessing spiritual well-being with a 7-day recall period. Scores range 0-48 with a higher score indicating better spiritual well-being.

  14. Change from Baseline on Functional Assessment of Chronic Illness Therapy-Spiritual Well-being 12-item scale (FACIT-Sp-12) at Week 2. [ Time Frame: Baseline and Week 2 ]
    The FACIT-Sp-12 is a validated, patient-reported outcome assessing spiritual well-being with a 7-day recall period. Scores range 0-48 with a higher score indicating better spiritual well-being.

  15. Change from Baseline on Hopelessness Assessment in Illness Questionnaire (HAI) at Week 5. [ Time Frame: Baseline and Week 5 ]
    The HAI is a validated patient-reported measure of hopelessness in terminally ill cancer patients. Scores range 0-16 with higher scores indicating higher levels of hopelessness.

  16. Change from Baseline on Hopelessness Assessment in Illness Questionnaire (HAI) at Week 2. [ Time Frame: Baseline and Week 2 ]
    The HAI is a validated patient-reported measure of hopelessness in terminally ill cancer patients. Scores range 0-16 with higher scores indicating higher levels of hopelessness.

  17. Relative risks for treatment-related, clinically significant adverse events [ Time Frame: Through study completion (up to 4 months) ]
    Relative risks for treatment-related serious adverse events, unexpected adverse events, common adverse events, and adverse events of special interest


Other Outcome Measures:
  1. Treatment Allocation Questionnaire (TAQ) at Week 2. [ Time Frame: Baseline and Week 2 ]
    The TAQ is a questionnaire made for this study. Participants will be asked what study drug they believed they received at their medication visit (psilocybin or ketamine). They will then be asked to rate with which certainty they believe this using a visual analog scale 0-100%.

  2. Treatment Allocation Questionnaire (TAQ) at Week 5. [ Time Frame: Baseline and Week 5 ]
    The TAQ is a questionnaire made for this study. Participants will be asked what study drug they believed they received at their medication visit (psilocybin or ketamine). They will then be asked to rate with which certainty they believe this using a visual analog scale 0-100%.

  3. Mystical Experience Questionnaire-30 (MEQ30) at Medication Visit. [ Time Frame: At the end of the Medication Visit (Visit 4 / Day 0) ]
    The MEQ30 is a validated, patient-reported outcome assessing mystical-type experiences, derived from the earlier surveys of subjective responses to psilocybin. Scores range 0-150 with a higher score indicating a more mystical-type experience.

  4. Challenging Experience Questionnaire (ChEQ) at Medication Visit. [ Time Frame: At the end of the Medication Visit (Visit 4 / Day 0) ]
    The ChEQ is a validated, patient-reported outcome assessing challenging experiences with psychedelics. Possible scores range 0-130 with a higher score indicating greater psychologically adverse reactions to psilocybin.

  5. Change from Baseline in 15-item Death Transcendence Scale (DTS-15) at Week 1. [ Time Frame: Baseline and Week 1 ]
    The DTS-15 is a validated, patient-reported outcome assessing death transcendence. Possible scores range 0-60 with a higher score indicating a higher level of death transcendence.

  6. Persisting Effects Questionnaire 4-item (PEQ-4) at Week 5. [ Time Frame: Week 5 ]
    The PEQ-4 is a patient-reported outcome assessing the enduring effects of psilocybin. Ratings are made with respect to other life experiences. Possible scores range 0-32 with a higher score indicating higher enduring effects of psilocybin.

  7. Change in patient-reported pain from Baseline in Brief Pain Inventory-Short Form (BPI-SF) at Week 5. [ Time Frame: Baseline and Week 5 ]
    The BPI-SF is a validated, patient-reported outcome assessing pain over the last 24-hours, with higher scores on subscales indicating higher severity of pain, and/or higher impact on functioning. This measure will assess change in pain in the subset of patients with moderate-to-severe pain at Baseline.

  8. Change in patient-reported pain from Baseline in Brief Pain Inventory-Short Form (BPI-SF) at Week 2. [ Time Frame: Baseline and Week 2 ]
    The BPI-SF is a validated, patient-reported outcome assessing pain over the last 24-hours, with higher scores on subscales indicating higher severity of pain, and/or higher impact on functioning. This measure will assess change in pain in the subset of patients with moderate-to-severe pain at Baseline.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

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
  • Antidepressants (with exceptions)
  • Dopamine agonists
  • Drugs known to have adverse interactions with psilocybin or ketamine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05403086


Contacts
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Contact: Charles S. Grob, M.D. (310) 961-2662 psilocybin@lundquist.org
Contact: Brian T Anderson, M.D. (310) 961-2662 psilocybin@lundquist.org

Sponsors and Collaborators
Charles S. Grob, M.D.
University of California, San Francisco
Investigators
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Principal Investigator: Charles S. Grob, M.D. Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Publications:

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Responsible Party: Charles S. Grob, M.D., Professor of Psychiatry and Behavioral Sciences, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
ClinicalTrials.gov Identifier: NCT05403086    
Other Study ID Numbers: 21-008459
First Posted: June 3, 2022    Key Record Dates
Last Update Posted: October 24, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data from this study may be requested from other researchers 2 years after the completion of the primary endpoint by contacting the study sponsor.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data will become available 2 years after completion of the primary endpoint.
Access Criteria: Data will be made available to qualified investigators who agree to the data sharing policies of the study.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Charles S. Grob, M.D., Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center:
Palliative Care
Serious Medical Illness
Life-threatening Condition
Advanced and Progressive Illness
Additional relevant MeSH terms:
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Ketamine
Psilocybin
Hallucinogens
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Psychotropic Drugs