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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    15
  • sponsor
    Yvan Beaussant
Updated on 8 June 2022

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

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.

Details
Condition Hospice, Psilocybin, Demoralization, Terminal Illness, Cancer-related Problem/Condition, Psychotherapy, Terminal Cancer, Cancer Terminal
Treatment Psychotherapy, Psilocybin
Clinical Study IdentifierNCT04950608
SponsorYvan Beaussant
Last Modified on8 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients enrolled in hospice care at home
Age ≥ 21 years

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
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