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Pragmatic Trial of Psilocybin Therapy in Palliative Care (PT2PC)

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ClinicalTrials.gov Identifier: NCT05403086
Recruitment Status : Not yet recruiting
First Posted : June 3, 2022
Last Update Posted : June 3, 2022
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

Tracking Information
First Submitted Date  ICMJE April 24, 2022
First Posted Date  ICMJE June 3, 2022
Last Update Posted Date June 3, 2022
Estimated Study Start Date  ICMJE October 1, 2022
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2022)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2022)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 1, 2022)
  • 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%.
  • 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%.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Pragmatic Trial of Psilocybin Therapy in Palliative Care
Official Title  ICMJE 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
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).
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Demoralization
Intervention  ICMJE
  • Drug: Psilocybin
    Psilocybin, [3-[2-(dimethylamino)ethyl]-1H-indol-4-yl] dihydrogen phosphate.
    Other Name: Hallucinogen
  • 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
Study Arms  ICMJE
  • Experimental: Psilocybin
    A single moderate-to-high dose of oral psilocybin, plus 4-5 sessions of a brief, existential psychotherapy.
    Intervention: Drug: Psilocybin
  • Active Comparator: Ketamine
    A single low-to-moderate dose of oral liquid ketamine, plus 4-5 sessions of a brief, existential psychotherapy.
    Intervention: Drug: Ketamine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 1, 2022)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2026
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

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

  • 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
  • Recent use of psychedelics or ketamine
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Charles S. Grob, M.D. (424) 306-5719 cgrob@lundquist.org
Contact: Brian T Anderson, M.D. Brian.Anderson@ucsf.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05403086
Other Study ID Numbers  ICMJE 21-008459
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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.
Current Responsible Party Charles S. Grob, M.D., Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Charles S. Grob, M.D.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE University of California, San Francisco
Investigators  ICMJE
Principal Investigator: Charles S. Grob, M.D. Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
PRS Account Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP