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Psilocybin Therapy in Advanced Cancer

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: NCT05398484
Recruitment Status : Not yet recruiting
First Posted : June 1, 2022
Last Update Posted : September 16, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE May 26, 2022
First Posted Date  ICMJE June 1, 2022
Last Update Posted Date September 16, 2022
Estimated Study Start Date  ICMJE November 1, 2022
Estimated Primary Completion Date January 1, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2022)
  • Change in GRID-Hamilton Depression Rating Scale (GRID-HAMD-17) Score [ Time Frame: Week 0, Week 8 ]
    GRID-Hamilton Depression Rating Scale (GRID-HAMD-17) measures the level of depression in participants. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the 17-point scale
  • Change in Hamilton Anxiety Scale Ham A (GRID-Ham-A) [ Time Frame: Week 0, Week 8 ]
    Hamilton Anxiety Scale Ham A (GRID-Ham-A) measures the severity of a patient's anxiety in participants. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2022)
  • Change in Hospital Anxiety and Depression Scale (HADS) - Depression Subscale Score [ Time Frame: Baseline, Week 8 ]
    The Hospital Anxiety and Depression Scale (HADS) is comprised of seven questions about depression. The total score range is 0-21 with each answer ranging from 0 (absence) to 3 (extreme presence). Higher scores indicate greater levels of depression.
  • Change in Hospital Anxiety and Depression Scale (HADS) - Depression Subscale Score [ Time Frame: Baseline, Week 12 ]
    The Hospital Anxiety and Depression Scale (HADS) is comprised of seven questions about depression. The total score range is 0-21 with each answer ranging from 0 (absence) to 3 (extreme presence). Higher scores indicate greater levels of depression.
  • Change in Hospital Anxiety and Depression Scale (HADS) - Depression Subscale Score [ Time Frame: Baseline, Month 6 ]
    The Hospital Anxiety and Depression Scale (HADS) is comprised of seven questions about depression. The total score range is 0-21 with each answer ranging from 0 (absence) to 3 (extreme presence). Higher scores indicate greater levels of depression.
  • Change in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score [ Time Frame: Baseline, Week 8 ]
    The Hospital Anxiety and Depression Scale (HADS) is comprised of seven questions about anxiety. The total score range is 0-21 with each answer ranging from 0 (absence) to 3 (extreme presence). Higher scores indicate greater levels of depression.
  • Change in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score [ Time Frame: Baseline, Week 12 ]
    The Hospital Anxiety and Depression Scale (HADS) is comprised of seven questions about anxiety. The total score range is 0-21 with each answer ranging from 0 (absence) to 3 (extreme presence). Higher scores indicate greater levels of depression.
  • Change in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score [ Time Frame: Baseline, Month 6 ]
    The Hospital Anxiety and Depression Scale (HADS) is comprised of seven questions about anxiety. The total score range is 0-21 with each answer ranging from 0 (absence) to 3 (extreme presence). Higher scores indicate greater levels of depression.
  • Change in Functional Assessment of Cancer Therapy-General (FACT-G) Score [ Time Frame: Baseline, Week 8 ]
    The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire designed to measure four domains of Health-related quality of life (HRQOL) in cancer patients: Physical, social, emotional, and functional well-being. All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much). The FACT-G total score is computed as the sum of the four subscale scores, provided the overall item response is at least 80% (i.e., at least 22 of the 27 items were answered) and has a possible range of 0-108 points. The lower the score, the greater the quality of life
  • Change in Functional Assessment of Cancer Therapy-General (FACT-G) Score [ Time Frame: Baseline, Week 12 ]
    The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire designed to measure four domains of Health-related quality of life (HRQOL) in cancer patients: Physical, social, emotional, and functional well-being. All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much). The FACT-G total score is computed as the sum of the four subscale scores, provided the overall item response is at least 80% (i.e., at least 22 of the 27 items were answered) and has a possible range of 0-108 points. The lower the score, the greater the quality of life
  • Change in Functional Assessment of Cancer Therapy-General (FACT-G) Score [ Time Frame: Baseline, Month 6 ]
    The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire designed to measure four domains of Health-related quality of life (HRQOL) in cancer patients: Physical, social, emotional, and functional well-being. All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much). The FACT-G total score is computed as the sum of the four subscale scores, provided the overall item response is at least 80% (i.e., at least 22 of the 27 items were answered) and has a possible range of 0-108 points. The lower the score, the greater the quality of life
  • Change in Functional Assessment of Chronic Illness Therapy-Spiritual well-being, 12-items (FACIT-Sp-12) Score [ Time Frame: Baseline, Week 8 ]
    The Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-Sp-12) is a 12-item questionnaire that measures spiritual well-being in people with cancer and other chronic illnesses. Answers are scored on a 5-point Likert scale from 0 to 4. Total scores range from 0 to 48, higher scores indicating higher spiritual well-being.
  • Change in Functional Assessment of Chronic Illness Therapy-Spiritual well-being, 12-items (FACIT-Sp-12) Score [ Time Frame: Baseline, Week 12 ]
    The Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-Sp-12) is a 12-item questionnaire that measures spiritual well-being in people with cancer and other chronic illnesses. Answers are scored on a 5-point Likert scale from 0 to 4. Total scores range from 0 to 48, higher scores indicating higher spiritual well-being.
  • Change in Functional Assessment of Chronic Illness Therapy-Spiritual well-being, 12-items (FACIT-Sp-12) Score [ Time Frame: Baseline, Month 6 ]
    The Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-Sp-12) is a 12-item questionnaire that measures spiritual well-being in people with cancer and other chronic illnesses. Answers are scored on a 5-point Likert scale from 0 to 4. Total scores range from 0 to 48, higher scores indicating higher spiritual well-being.
  • Change in Healing Experience of All Life Stressors (NIH-HEALS) Score [ Time Frame: Baseline, Week 8 ]
    Healing Experience of All Life Stressors (NIH-HEALS) was developed by the NIH Clinical Center Pain and Palliative Care Service as a psycho-social-spiritual measure of healing that assesses positive transformation in response to challenging life events. It is a self-report, 35-item questionnaire. It is scored on a five-point Likert scale from Strongly Disagree (1) to Strongly Agree (5). The total score range is 35-175; higher scores reflect more positive response to life stressors.
  • Change in Healing Experience of All Life Stressors (NIH-HEALS) Score [ Time Frame: Baseline, Week 12 ]
    Healing Experience of All Life Stressors (NIH-HEALS) was developed by the NIH Clinical Center Pain and Palliative Care Service as a psycho-social-spiritual measure of healing that assesses positive transformation in response to challenging life events. It is a self-report, 35-item questionnaire. It is scored on a five-point Likert scale from Strongly Disagree (1) to Strongly Agree (5). The total score range is 35-175; higher scores reflect more positive response to life stressors.
  • Change in Healing Experience of All Life Stressors (NIH-HEALS) Score [ Time Frame: Baseline, Month 6 ]
    Healing Experience of All Life Stressors (NIH-HEALS) was developed by the NIH Clinical Center Pain and Palliative Care Service as a psycho-social-spiritual measure of healing that assesses positive transformation in response to challenging life events. It is a self-report, 35-item questionnaire. It is scored on a five-point Likert scale from Strongly Disagree (1) to Strongly Agree (5). The total score range is 35-175; higher scores reflect more positive response to life stressors.
  • Changes in Demoralization scale (DS) Score [ Time Frame: Baseline, Week 8 ]
    The Demoralization scale (DS) is a validated and frequently used instrument to assess existential distress in patients with cancer and other severe medical illness. Items are rated on a 5-point Likert scale ranging from 0 (never) to 4 (all the time). A total score for demoralization is calculated by summarizing the single subscale scores; the total score range is 0-52. Higher scores indicate higher levels of demoralization.
  • Changes in Demoralization scale (DS) Score [ Time Frame: Baseline, Week 12 ]
    The Demoralization scale (DS) is a validated and frequently used instrument to assess existential distress in patients with cancer and other severe medical illness. Items are rated on a 5-point Likert scale ranging from 0 (never) to 4 (all the time). A total score for demoralization is calculated by summarizing the single subscale scores; the total score range is 0-52. Higher scores indicate higher levels of demoralization.
  • Changes in Demoralization scale (DS) Score [ Time Frame: Baseline, Month 6 ]
    The Demoralization scale (DS) is a validated and frequently used instrument to assess existential distress in patients with cancer and other severe medical illness. Items are rated on a 5-point Likert scale ranging from 0 (never) to 4 (all the time). A total score for demoralization is calculated by summarizing the single subscale scores; the total score range is 0-52. Higher scores indicate higher levels of demoralization.
  • Change in Life Attitude Profile-Revised (LAP-R) Death Acceptance Scale Score [ Time Frame: Baseline, Week 8 ]
    Life Attitude Profile-Revised (LAP-R) Death Acceptance scale is a 48-item self-report multidimensional measure of discovered meaning and purpose in life and the motivation to find meaning and purpose in life. Each item was rated on a 7-point Likert scale ranging from "strongly disagree" (1) to "strongly agree" (7). The total score range is 48-336. Higher Scores indicate a more meaningful positive attitude towards life.
  • Change in Life Attitude Profile-Revised (LAP-R) Death Acceptance Scale Score [ Time Frame: Baseline, Week 12 ]
    Life Attitude Profile-Revised (LAP-R) Death Acceptance scale is a 48-item self-report multidimensional measure of discovered meaning and purpose in life and the motivation to find meaning and purpose in life. Each item was rated on a 7-point Likert scale ranging from "strongly disagree" (1) to "strongly agree" (7). The total score range is 48-336. Higher Scores indicate a more meaningful positive attitude towards life.
  • Change in Life Attitude Profile-Revised (LAP-R) Death Acceptance Scale Score [ Time Frame: Baseline, Month 6 ]
    Life Attitude Profile-Revised (LAP-R) Death Acceptance scale is a 48-item self-report multidimensional measure of discovered meaning and purpose in life and the motivation to find meaning and purpose in life. Each item was rated on a 7-point Likert scale ranging from "strongly disagree" (1) to "strongly agree" (7). The total score range is 48-336. Higher Scores indicate a more meaningful positive attitude towards life.
  • Mystical Experience Questionnaire-30 items (MEQ-30) Score [ Time Frame: 8 hours post-medication ]
    The Mystical Experience Questionnaire (MEQ) is an unvalidated self-report measure that has been used to measure mystical-type experiences in laboratory studies of hallucinogens. Scoring consists of 0 - none; not at all; 1 - so slight cannot decide; 2 - slight; 3- moderate; 4 - strong (equivalent in degree to any other strong experience); 5- extreme (more than any other time in my life and stronger than 4). MEQ30 total scores range from 0 to 150; the higher the score, the greater the mystical-type experiences occasioned by psilocybin
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Psilocybin Therapy in Advanced Cancer
Official Title  ICMJE A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study of the Effects of Psilocybin-assisted Psychotherapy on Psychiatric and Existential Distress in Advanced Cancer
Brief Summary The purpose of this research is to study the safety and effects of single-dose psilocybin 25mg versus an active placebo (single dose psilocybin 1mg) in the treatment of anxiety, depression, and existential distress (i.e. loss of meaning and hope; fear of death) in advanced cancer (i.e. stage 3 or 4). Study medications will be administered in conjunction with brief psychotherapy that is designed to treat anxiety, depression and existential distress in advanced cancer.
Detailed Description This trial is designed to evaluate efficacy and psychological mechanisms of single-dose psilocybin-assisted psychotherapy (PAP) to treat psychiatric (depression, anxiety) and existential distress (demoralization, death anxiety), and quality-of-life (QOL), in 200 outpatients with late-stage (stage 3 or 4) cancer. The study will assess the strength and durability of therapeutic effects in a double-blind, parallel-design, placebo-controlled, two-center RCT comparing a single 25mg oral 'high' dose of psilocybin to a single 1mg 'very low' (clinically non-therapeutic) dose active control psilocybin, both delivered in conjunction with a psychotherapy platform.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Advanced Cancer
Intervention  ICMJE
  • Drug: Psilocybin 25 mgs
    One capsule containing 25mg of psilocybin will be administered with water orally. The appearance of psilocybin is Size 2 HPMC opaque.
  • Drug: Psilocybin 1 mg
    One capsule contains 1mg of psilocybin will be administered with water orally. The appearance of the active placebo is Size 2 HPMC opaque.
  • Behavioral: Psychotherapy
    The manualized psychotherapy platform will consist of 6 hours of preparatory psychotherapy (prior to the single medication session) and 8 hours of integration psychotherapy following the dosing session.
Study Arms  ICMJE
  • Experimental: Participants receiving Study Drug
    Stage III/IV cancer participants will receive experimental medication, psilocybin (25 mg). In addition to the pharmacologic intervention, participants will receive a manualized psychotherapy platform. The combination of interventions is referred to as psilocybin-assisted psychotherapy (PAP).
    Interventions:
    • Drug: Psilocybin 25 mgs
    • Behavioral: Psychotherapy
  • Active Comparator: Participants receiving Placebo
    Stage III/IV cancer participants will receive active placebo - 1 dose of psilocybin (1mg). In addition to the placebo, participants will receive the same manualized psychotherapy platform as the experimental arm.
    Interventions:
    • Drug: Psilocybin 1 mg
    • Behavioral: Psychotherapy
Publications * Not Provided

*   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: May 26, 2022)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2027
Estimated Primary Completion Date January 1, 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged ≥ 21
  • Diagnosis of Advanced (i.e. stage 3 or 4 solid tumors) Cancer
  • Functional Status defined Eastern Cooperative Oncology Group (ECOG) ≤2 and Palliative Performance Scale (PPS) ≥60%
  • Clinically significant Depression/Anxiety, with Hospital Anxiety and Depression (HADS) Total score >12 at Screening OR Clinically significant Existential Distress defined as Demoralization Scale Total score >30 and clinically significant Anxiety and Depression defined as HADS total >8

Exclusion Criteria:

  • Unstable medical conditions or serious abnormalities of complete blood count, chemistries, or ECG that in the opinion of the study physician would preclude safe participation in the trial. Some examples include

    • Congestive heart failure
    • Clinically significant arrhythmias (e.g. ventricular fibrillation, torsades) or clinically significant ECG abnormality (i.e. QTC interval > 450)
    • Recent acute myocardial infarction or evidence of ischemia
    • Malignant hypertension
    • Congenital long QT syndrome
    • Acute renal failure
    • Severe hepatic impairment
    • Respiratory failure
  • Risk for hypertensive crisis defined as Screening, Baseline, and Medication Session (prior to dosing) Blood Pressure >140/90 mmHg.
  • Significant central nervous system (CNS) pathology. Some examples include:

    • Primary or secondary cerebral neoplasm
    • Epilepsy
    • History of stroke
    • Cerebral aneurysm
    • Dementia
    • Delirium
  • Primary psychotic or affective psychotic disorders. Some examples include current or past DSM-V criteria for:

    • Schizophrenia spectrum disorders
    • Schizoaffective disorder
    • Bipolar I with psychotic features
    • Major Depressive Disorder with psychotic features
  • High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation. Examples include

    • Evidence of serious personality disorder (e.g. anti-social personality disorder)
    • Agitation
    • Violent behavior
  • Active substance use disorders (SUDs) defined as: DSM-5 criteria for alcohol or drug use disorder (excluding caffeine and nicotine) within the past year
  • Extensive use of serotonergic hallucinogens (e.g. LSD, psilocybin) defined as:

    • Any use in the last 12 months
    • >25 lifetime uses
  • Clinically significant suicidality or high risk of completed suicide defined as

    • Active suicidal behavior (interrupted or aborted attempt; preparatory acts) as assessed by Baseline Version of CSSRS. If CSSRS items are 4 or 5, participant is ineligible
    • History of suicide attempt(s) within the past year
  • History of hallucinogen persisting perception disorder (HPPD)
  • Cognitive impairment as defined by: Montreal Cognitive Assessment Test (MoCA) < 23
  • Concurrent Medications

    • Antidepressants
    • Centrally-acting serotonergic agents (e.g. MAO inhibitors)
    • Antipsychotics (e.g. first and second generation)
    • Mood stabilizers (e.g. lithium, valproic acid)
    • Aldehyde dehydrogenase inhibitors (e.g. disulfiram)
    • Significant inhibitors of UGT 1A0 or UGT 1A10
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Angela West 212-263-6283 angela.west@nyulangone.org
Contact: Stephen Ross, MD 212-263-6289 stephen.ross@nyulangone.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05398484
Other Study ID Numbers  ICMJE 22-00498
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access Criteria: The investigator who proposed to use the data. Upon reasonable request. Requests should be directed to Stephen.ross@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Current Responsible Party NYU Langone Health
Original Responsible Party Same as current
Current Study Sponsor  ICMJE NYU Langone Health
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Stephen Ross, MD NYU Langone Medical Center
PRS Account NYU Langone Health
Verification Date May 2022

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