Clinical trial NCT04950608: Pilot Study of Psilocybin-Assisted Therapy for Demoralization in Patients Receiving Hospice Care
Official title: Pilot Study of Psilocybin-Assisted Therapy for Demoralization in Patients Receiving Hospice Care - PATH Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Hospice
Psilocybin
Demoralization
Terminal Illness
Cancer-related Problem/Condition
Psychotherapy
Terminal Cancer
Cancer Terminal
Keywords: Hospice
Psilocybin
Demoralization
Terminal Illness
Cancer related terminal illness
psychotherapy
Terminal Cancer
Cancer Terminal
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Oppenheimer Family Psychosocial Oncology and Palliative Care Research Grants
name: Usona Institute
name: Carey and Claudia Turnbull Family Foundation
name: Heffter Research Institute
name: George Sarlo Foundation
name: RiverStyx Foundation
name: Council on Spiritual Practices Fund at the San Francisco Foundation
name: Nikean Foundation
name: Jack Smith
First posted: 2021-07-06
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility 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.

Primary outcomes:
measure: Number of participants screened per month
timeFrame: Through study completion, an average of 1 year
measure: Number of participants enrolled per month
timeFrame: Through study completion, an average of 1 year
measure: Average time delay from screening to enrollment
timeFrame: Through study completion, an average of 1 year
measure: Mean number of sessions completed by enrolled participants
timeFrame: Through study completion, an average of 1 year
measure: Proportion of planned assessments that are completed; duration of assessment visits
timeFrame: Through study completion, an average of 1 year
measure: Duration of assessment visits
timeFrame: Through study completion, an average of 1 year
measure: Mean score of acceptability ratings on Reactions to Research Participation Questionnaire Revised (RRPQR)
timeFrame: At Week 1 post dosing session
Secondary outcomes:
measure: Safety Outcomes: Adverse Events (AEs) and Serious Adverse Events (SAEs) as assessed by treating Investigator/PI (MD)
timeFrame: Through study completion, an average of 1 year
measure: Safety Outcomes: Suicidal Risk as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: From enrollment up to 10 days after dosing session
measure: Safety Outcomes: Delirium as assessed by Confusion Assessment Method (CAM)
timeFrame: From enrollment up to 10 days post dosing session
measure: Change in Global Quality Life Score as assessed by Functional Assessment of Chronic Illness Therapy - Palliative Care 14 (FACIT-Pal 14)
timeFrame: At Baseline, and every visit post intervention (dosing sessions) from Week 1 to week 24
measure: Change in Physical domain score as assessed by PROMIS Pain Interference Scale (PIS)
timeFrame: At Baseline, and every visit post intervention (dosing sessions) from Week 1 to week 24
measure: Change in Hospital Anxiety and Depression Scale (HADS A and D) Score
timeFrame: At Baseline and every visit pre and post intervention (dosing session) up to 24 weeks
measure: Change in Life Attitude Profile - revised, Death acceptance subscale (LAP-R) Score
timeFrame: At Baseline, and every visit post intervention (dosing sessions) from Week 1 to week 24
measure: Change in Challenging Experience Questionnaire (CEQ) Score
timeFrame: Immediately after the intervention, at the end of the dosing day
measure: Change in Social Isolation Scale (SIS) Score
timeFrame: At Baseline, and every visit post intervention (dosing sessions) from Week 1 to week 24
measure: Change in Spiritual Domain Score as assessed by Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 (FACIT-sp-12)
timeFrame: At Baseline, and every visit post intervention (dosing sessions) from Week 1 to week 24
measure: Change in Spiritual Domain Score as assessed by Schedule of Attitudes toward Hastened Death (SAHD)
timeFrame: At Baseline, and every visit post intervention (dosing sessions) from Week 1 to week 24
measure: Change in Spiritual Domain Score-Demoralization Scale (DS-II)
timeFrame: At Baseline and every visit pre and post intervention (dosing session) up to 24 weeks
measure: Change in Spiritual Domain Score Mystical Experience Questionnaire (MEQ-30)
timeFrame: Immediately after the intervention, at the end of the dosing day
measure: Change in Caregiver- CarGOQoL Score
timeFrame: At Baseline, and every visit post intervention (dosing sessions) from Week 1 to week 24
Other outcomes:
Locations:
city: Danvers
country: United States
facility: Care Dimensions
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Yvan Beaussant, MD
role: PRINCIPAL_INVESTIGATOR
References: