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Pilot Study of Psilocybin-Assisted Therapy for Demoralization in Patients Receiving Hospice Care (PATH)

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: NCT04950608
Recruitment Status : Recruiting
First Posted : July 6, 2021
Last Update Posted : May 24, 2022
Sponsor:
Collaborators:
Oppenheimer Family Psychosocial Oncology and Palliative Care Research Grants
Usona Institute
Carey and Claudia Turnbull Family Foundation
Heffter Research Institute
George Sarlo Foundation
RiverStyx Foundation
Council on Spiritual Practices Fund at the San Francisco Foundation
Nikean Foundation
Jack Smith
Information provided by (Responsible Party):
Yvan Beaussant, Dana-Farber Cancer Institute

Brief Summary:

The overall objective of this study is to develop and pilot test a novel regimen of psilocybin-assisted psychotherapy for demoralization in patients receiving hospice care.

-The name of the study drug involved in this study is Psilocybin


Condition or disease Intervention/treatment Phase
Hospice Psilocybin Demoralization Terminal Illness Cancer-related Problem/Condition Psychotherapy Terminal Cancer Cancer Terminal Drug: Psilocybin Behavioral: Psychotherapy Phase 2

Detailed Description:

The purpose of this research is to understand how psilocybin-assisted therapy may be adapted in the context of hospice care, in order to test its safety in people with terminal illness who experience demoralization, and to study how well it works to lessen symptoms of psychological and existential distress.

  • This research study involves a combined drug and psychotherapeutic (talk therapy) intervention. The research study procedures include screening for eligibility, and study intervention including preparation, evaluations, one psilocybin session and follow up visits.

    • The treatment regimen consists of a single administration of psilocybin with a supportive psychotherapy including 2 preparation sessions and 2 integration sessions
    • The name of the study drug involved in this study is Psilocybin. Psilocybin is a naturally occurring psychedelic drug produced by more than 200 species of mushrooms, which is manufactured for medical use to control potency and purity.
  • Participants will be followed for up to 24 weeks (approximately 6 months) after the study treatment. It is expected that about 15 people will take part in this research study.
  • This research study is a Feasibility Study, which mean it is the first time investigators are examining psilocybin-assisted therapy in the context of hospice care. Psilocybin is an "Investigational" drug, meaning that the study drug has not been approved by the U.S. Food and Drug Administration (FDA) as a treatment for any disease. However, the FDA has granted psilocybin the status of "breakthrough therapy" in the treatment of depression and the investigators have permission from the FDA to use this drug in this research study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Psilocybin-Assisted Therapy for Demoralization in Patients Receiving Hospice Care - PATH Study
Actual Study Start Date : March 9, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hospice Care

Arm Intervention/treatment
Experimental: PATH

The research study procedures include screening for eligibility, and study intervention including preparation, evaluations, one psilocybin session and follow up visits.

-The treatment regimen consists of a single administration of psilocybin 25 mg orally combined with a supportive psychotherapy including 2 preparation sessions and 2 integration sessions

Drug: Psilocybin
Oral, single administration, dosage 25 mg orally

Behavioral: Psychotherapy
The treatment regimen consists of a single administration of psilocybin orally combined with a supportive psychotherapy including 2 preparation sessions and 2 integration sessions




Primary Outcome Measures :
  1. Number of participants screened per month [ Time Frame: Through study completion, an average of 1 year ]
    This measurement will assess enrollment feasibility based on the screening log.

  2. Number of participants enrolled per month [ Time Frame: Through study completion, an average of 1 year ]
    This measurement will assess enrollment feasibility based on the screening log.

  3. Average time delay from screening to enrollment [ Time Frame: Through study completion, an average of 1 year ]
    This measurement will assess enrollment feasibility based on the screening log.

  4. Mean number of sessions completed by enrolled participants [ Time Frame: Through study completion, an average of 1 year ]
    This measurement will assess retention feasibility.

  5. Proportion of planned assessments that are completed; duration of assessment visits [ Time Frame: Through study completion, an average of 1 year ]
    This measurement will evaluate assessment feasibility.

  6. Duration of assessment visits [ Time Frame: Through study completion, an average of 1 year ]
    This measurement will evaluate assessment feasibility.

  7. Mean score of acceptability ratings on Reactions to Research Participation Questionnaire Revised (RRPQR) [ Time Frame: At Week 1 post dosing session ]
    This measurement will assess acceptability.


Secondary Outcome Measures :
  1. Safety Outcomes: Adverse Events (AEs) and Serious Adverse Events (SAEs) as assessed by treating Investigator/PI (MD) [ Time Frame: Through study completion, an average of 1 year ]
    Longitudinal follow-up and analysis of the relationship with psilocybin-assisted therapy.

  2. Safety Outcomes: Suicidal Risk as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: From enrollement up to 10 days after dosing session ]
    Assessment of suicidal ideations or plans. The measurement of suicidal ideation is based on five "yes" or "no" questions with accompanying descriptions arranged in order of increasing severity. If the patient answers "yes" to either questions 1 or 2, the intensity of ideation is assessed in five additional questions related to frequency, duration, controllability, deterrents, and reasons for the most severe suicidal ideation. Suicidal behavior is assessed by asking questions categorizing behaviors into actual, aborted, and interrupted attempts; preparatory behavior; and non-suicidal self-injurious behavior. A significant suicide risk is defined by suicidal ideation with intend and a plan as endorsed on item 5 on the C-SSRS within the past month at V0 or since previous visit later during the study.

  3. Safety Outcomes: Delirium as assessed by Confusion Assessment Method (CAM) [ Time Frame: From enrollment up to 10 days post dosing session ]
    Confusion Assessment Method (CAM) screens for a diagnosis of delirium via an assessment of the presence, severity and fluctuation of 9 delirium features: acute onset, inattention, disorganized thinking, altered level of consciousness, disorientation, memory impairment, perceptual disturbances, psychomotor agitation or retardation, and altered sleep-wake cycle.

  4. Change in Global Quality Life Score as assessed by Functional Assessment of Chronic Illness Therapy - Palliative Care 14 (FACIT-Pal 14) [ Time Frame: At Baseline, and every visit post intervention (dosing sessions) from Week 1 to week 24 ]
    Functional Assessment of Chronic Illness Therapy - Palliative Care 14 (FACIT-Pal 14) consists in 14 items, and subjects rate how they felt during the previous week on a 5-point Likert scale

  5. Change in Physical domain score as assessed by Edmonton Symptom Assessment System (ESAS) [ Time Frame: At Baseline and every visit pre and post intervention (dosing session) up to 24 weeks ]
    Edmonton Symptom Assessment System (ESAS) is a valid and reliable assessment tool to assist in the assessment of nine common symptoms experienced at the time of assessment by patients in palliative care: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath. One blank scale is available for patients to use to assess an "other problem" as needed. The severity at the time of assessment of each symptom is rated from 0 to 10 on a numerical scale; with 0 meaning that the symptom is absent and 10 that it is the worst possible severity

  6. Change in Physical domain score as assessed by PROMIS Pain Interference Scale (PIS) [ Time Frame: At Baseline, and every visit post intervention (dosing sessions) from Week 1 to week 24 ]
    The PROMIS-Pain Interference Scale (PIS) measures the self-reported consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. We will use 8 validated items pertaining to social and emotional consequences of pain during the previous week, that subjects will rate on a 5-point Likert scale

  7. Change in Hospital Anxiety and Depression Scale (HADS A and D) Score [ Time Frame: At Baseline and every visit pre and post intervention (dosing session) up to 24 weeks ]
    It is a self-report questionnaire consisting of 14 items, and subjects rate how they felt during the previous week on a 4-point Likert scale. The HADS consists of an anxiety and depression subscale (0-21 points each), and total scores can range from 0 to 42. Higher scores indicate more severe depression and anxiety.

  8. Change in Life Attitude Profile - revised, Death acceptance subscale (LAP-R) Score [ Time Frame: At Baseline, and every visit post intervention (dosing sessions) from Week 1 to week 24 ]
    Life Attitude Profile - revised, Death acceptance subscale (LAP-R Death Acceptance) is a validated, self-rated 9-item, 7-point Likert scale assessing acceptance and anxiety about death

  9. Change in Challenging Experience Questionnaire (CEQ) Score [ Time Frame: Immediately after the intervention, at the end of the dosing day ]
    The CEQ is a validated instrument with 26 items rated on a 5-item Likert scale, characterizing psychologically difficult aspects of experiences occasioned by psilocybin, according to seven factors: grief, fear, death, insanity, isolation, physical distress, and paranoia.

  10. Change in Social Isolation Scale (SIS) Score [ Time Frame: At Baseline, and every visit post intervention (dosing sessions) from Week 1 to week 24 ]
    The PROMIS SIS-6 assesses perceptions of being avoided, excluded, detached, disconnected from, or unknown by, others. We will use the short form of the instrument consisting in a 6-item, 5-point Likert scale

  11. Change in Spiritual Domain Score as assessed by Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 (FACIT-sp-12) [ Time Frame: At Baseline, and every visit post intervention (dosing sessions) from Week 1 to week 24 ]
    The Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 (FACIT-sp-12) scale is a measure of spiritual well-being validated for use in cancer and widely used in palliative care research. The FACIT-sp-12 has subscales that measure faith, meaning and peace, which are broadly consistent with conceptual models of spiritual wellbeing.

  12. Change in Spiritual Domain Score as assessed by Schedule of Attitudes toward Hastened Death (SAHD) [ Time Frame: At Baseline, and every visit post intervention (dosing sessions) from Week 1 to week 24 ]
    The Schedule of Attitudes toward Hastened Death (SAHD) is a reliable and valid measure of desire for death among terminally ill patients. It includes 20 items that subjects rate as true or false.

  13. Change in Spiritual Domain Score-Demoralization Scale (DS-II) [ Time Frame: At Baseline and every visit pre and post intervention (dosing session) up to 24 weeks ]
    It's a 3-point response, self-report scale comprising 16 items and 2 subscales (meaning and purpose, and distress and coping ability). The presence of baseline moderate-to-severe demoralization, as measure by a DS-II score ≥ 8, is necessary for inclusion in this study.

  14. Change in Spiritual Domain Score Mystical Experience Questionnaire (MEQ-30) [ Time Frame: Immediately after the intervention, at the end of the dosing day ]
    The MEQ-3056 is a self-report questionnaire that evaluates discrete mystical experiences induced by serotoninergic psychedelics and is sensitive to detecting psilocybin-induced mystical experiences.

  15. Change in Caregiver- CarG OQoL Score [ Time Frame: At Baseline, and every visit post intervention (dosing sessions) from Week 1 to week 24 ]
    The CarGOQoL is a well-designed and well-validated 29-item, multidimensional, self-administered questionnaire assessing QoL of cancer caregivers.



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

Inclusion Criteria:

  • Patients enrolled in hospice care at home
  • Age ≥ 21 years.
  • Any terminal illness with respect of exclusion criteria
  • Palliative Performance Scale (PPS) ≥ 50 % (see Appendix A)
  • Moderate-to-severe demoralization as measured by Demoralization Scale-II ≥ 8
  • Significant other or other caregiver present at home the night of study drug administration
  • No driving for 24 hours following study drug administration.
  • English proficiency
  • Ability to understand and the willingness to sign a written informed consent document.
  • Psilocybin is very likely to have no genotoxic effects. One study that directly focused on the mutagenic potential of psilocybin did not found this type of toxicity. However, due to the lack of clinical and non-clinical studies on the effects of psilocybin on the developing human fetus, women and men of child-bearing potential and who are sexually active must agree to use an acceptable contraceptive method (hormonal or barrier method of birth control; abstinence) throughout their participation in the study. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of psilocybin administration.

Exclusion Criteria:

  • Current General Inpatient (GIP) hospice status
  • Patients currently receiving chemotherapy
  • Condition impairing oral intake or digestive absorption
  • Presence of a delirium diagnosed by the CAM
  • Significant suicide risk as defined by suicidal ideation with intend and a plan as endorsed on item 5 on the C-SSRS within the past month or at V0
  • Current or past history of schizophrenia, psychotic disorder, bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective disorder, or borderline personality disorder, as assessed by medical history
  • Patients with first-degree relatives with schizophrenia or bipolar disorder
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to psilocybin
  • Other personal circumstances and behavior that would limit compliance with study requirements, or judged by the study psychiatrist and/or principal investigator to be incompatible with establishment of rapport or safe exposure to psilocybin
  • Potential for adverse drug-drug interactions. Concomitant medications with significant potential to interact with study medications will be exclusionary if they cannot be tapered. These include the following:

    • Serotoninergic 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
  • Any psychiatric medication will be tapered if possible in an appropriate fashion to avoid withdrawal effects. They will be discontinued long enough before the psilocybin Session to avoid the possibility of any drug-drug interaction (the interval will be at least five times the particular drug and active metabolites' half-life).
  • End stage liver disease or cirrhosis as primary hospice diagnosis
  • Patients who have elevated AST and ALT five times above the normal laboratory limit on their last available bloodwork and patients with symptoms suggestive of liver failure including confusion, asterixis or jaundice.
  • Any other clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal condition or any other unstable condition that, in the opinion of the principal investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if he/she takes part in the study. This may include but is not limited to clinical symptoms or recent history of significant tachyarrhythmias; severe angina or myocardial ischemia; poorly controlled congestive heart failure; poorly controlled hypertension; poorly controlled hypo- or hyperthyroidism; uncontrolled diabetes; severe renal or liver disfunction; acute respiratory failure; sepsis; history of cerebral aneurysms; glaucoma; increased intracranial pressure and any intracranial mass.
  • Women who are pregnant, nursing, or planning a pregnancy.

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): NCT04950608


Contacts
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Contact: Susan Lysaght Hurley, PhD, GNP-BC (781)373-6608 research@caredimensions.org

Locations
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United States, Massachusetts
Care Dimensions Recruiting
Danvers, Massachusetts, United States, 01923
Contact: Caitlin Brennan, PhD, GNP-BC    781-373-6608    research@caredimensions.org   
Principal Investigator: Yvan Beaussant, MD         
Sub-Investigator: Zachary Sager, MD         
Sub-Investigator: James Tulsky, MD         
Sub-Investigator: Caitlin Brennan, PhD, GNP-BC         
Sub-Investigator: Ilana Braun, MD         
Sub-Investigator: Alifia Waliji-Banglawala, PharmD         
Sub-Investigator: Alden Rinaldi, MD         
Sponsors and Collaborators
Yvan Beaussant
Oppenheimer Family Psychosocial Oncology and Palliative Care Research Grants
Usona Institute
Carey and Claudia Turnbull Family Foundation
Heffter Research Institute
George Sarlo Foundation
RiverStyx Foundation
Council on Spiritual Practices Fund at the San Francisco Foundation
Nikean Foundation
Jack Smith
Investigators
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Principal Investigator: Yvan Beaussant, MD Dana-Farber Cancer Institute
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Responsible Party: Yvan Beaussant, Sponsor Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT04950608    
Other Study ID Numbers: 21-202
First Posted: July 6, 2021    Key Record Dates
Last Update Posted: May 24, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data can be shared no earlier than 1 year following the date of publication
Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yvan Beaussant, Dana-Farber Cancer Institute:
Hospice
Psilocybin
Demoralization
Terminal Illness
Cancer related terminal illness
psychotherapy
Terminal Cancer
Cancer Terminal
Additional relevant MeSH terms:
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Psilocybin
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs