Clinical trial NCT05958758: A Community of Practice Program With Psilocybin-assisted Therapy for End-of-Life Patients
Official title: An Open Label Pragmatic Feasibility Study on a Resilience Focused Community of Practice Program With Psilocybin-assisted Therapy (PaT) for End-of-Life Patients.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: End of Life
Lead sponsor: The Roots to Thrive Society for Psychedelic Therapy
Sponsor class: OTHER
Collaborators: name: Vancouver Island Health Authority
name: Vancouver Island University
First posted: 2023-07-25
Enrollment: 64
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to understand the feasibility of a resilience focused community of practice program that includes psilocybin-assisted therapy for End-of-Life Distress. The community of practice refers to a research informed group therapy process that runs over a 10-week period of time and includes one group administered psilocybin-assisted therapy session.

Target population: The treatment team will treat a total of 64 patients who have:

* a terminal diagnosis (experiencing end of life distress),
* AND who are eligible for the RTT + Psilocybin-assisted Therapy Treatment program through the RTT Society.

Detailed description: Treatment will take place at the Snuneymuxw Traditional Medicines Clinic, 1984 Woobank Rd, Nanaimo, B.C.Research data will be coordinated and held through RedCap, hosted by Island Health.

Data collection centres on 1) understanding the feasibility; 2) collecting safety data; 3) exploring the mental health impacts of a community of practice as the vessel for psilocybin-assisted therapy for those with end-of-life distress.

There is a mixed method approach for data collection, including:

* Collect attendance
* Biomedical measures taken during psilocybin sessions (blood pressure, pulse, medications to manage side effects).
* Quantitative Health and Wellness Questionnaires of participants before, within, immediately after, and six months after completion.
* Qualitative Surveys and Exit Interviews.

Eligibility criteria: Inclusion Criteria

* Patient must have a terminal diagnosis whereby there is a limited life expectancy (predicted life expectancy less than 2 years).
* Ages 19-80 years of age
* Male, menopausal female, if childbearing age not pregnant, using birth control and negative pregnancy test prior to psilocybin administration.
* Ambulatory (Palliative performance status 50% or greater)
* eGFR \>20 ml/min ❏AST \< 3xULN and bilirubin \<50 umol/L
* Patient has emotional distress that has not successfully responded to other treatments: other treatments failed, patient could not tolerate other treatments, patient is unable to access other treatments, or patient refused other treatments for reasons acceptable to our treatment team.
* Patient demonstrates comprehension sufficient for understanding the consent form.

Exclusion Criteria:

* Treatment in a clinical trial where psilocybin therapy would disqualify them from their primary treatment trial.
* If female is:a) pregnant (positive pregnancy test),b) nursing,
* Currently taking on a regular (e.g., daily) basis: \>investigational agents, \>medications that are MAO inhibitors \>UDG modulators, and inhibitors of UGT1A9 and 1A10, aldehyde or alcohol dehydrogenase inhibitors, SSRI's, SNRI's.

  * Patients are given the option to wean themselves off their medications prior to the psilocybin to be included in the trial. Patients taking MAO-A inhibitors (especially the irreversible inhibitors) will require a minimum 2-week washout period. The possible concern over serotonin syndrome with these agents is not well documented in the literature, however the long interval before MAO is replenished may warrant a cautious approach based on the patient's risk factors and warrants oversight from the MRP (Most Responsible Physician)
  * Patientstaking MAO-B inhibitors should be assessed on a case by case basis as there is a potential for a heightened response and warrants oversight from the MRP.
* Patients with known sensitivities to psilocybin and or its metabolites or have had significant adverse events after prior psilocybin or other psychedelic use.
* Active uncontrolled epilepsy.
* Uncontrolled cardiovascular conditions: uncontrolled hypertension, uncontrolled angina, a clinically significant ECG abnormality (e.g. QT prolongation).
* Uncontrolled vascular disease (such as TIA in the last 3-6 months, stroke with loss in mental status, peripheral or pulmonary vascular disease with active claudication).
* Unstable Insulin-dependent diabetes;

Conditions requiring special medical consideration:

* Cancer has central nervous system involvement.
* Paraneoplastic syndrome or a tumor with ectopic hormone production which may place the patient at risk for hypercalcemia, Cushing's syndrome, or SIADH secretion.

Psychiatric Exclusion Criteria:

* Severity of depression or anxiety symptoms warranting immediate emergent treatment with antidepressant or daily anxiolytic medication as these patients would require immediate referral to community psychiatry.
* Current or past history of meeting DSM-5 criteria for:

(the following diagnoses must have been confirmed by a qualified psychiatrist or psychologist):

* Schizophrenia;
* Psychotic Disorder (unless substance-induced or due to a medical condition);○ Borderline Personality Disorder;
* Bipolar I Disorder;
* Bipolar II Disorder;
* Other psychiatric conditions judged to be incompatible with establishment of rapport or safe exposure to psilocybin.

  * Borderline Personality Disorder, Bipolar I Disorder and Bipolar II Disorder may be considered after a psychiatric consult.
  * Bipolar I would require more in-depth investigation in relation to the history of manic episodes.

    * Meet DSM-5 criteria for Dissociative Disorder
    * Concurrent use of illicit drugs causing ongoing intoxication
    * Unstable housing conditions (homelessness)
    * First degree relatives meet DSM-5 criteria for Bipolar Disorder or Schizophrenia

Primary outcomes:
measure: Primary Outcome 1: Treatment Intervention Phase - Safety Monitoring: Adverse events (AEs), serious adverse events (SAEs) and treatment emergent adverse events (TEAEs)
timeFrame: Treatment intervention period: Weeks 1 through 10
measure: Primary Outcome 2: Follow-up to Treatment Phase - Safety Monitoring: Adverse events (AEs), serious adverse events (SAEs) and treatment emergent adverse events (TEAEs)
timeFrame: Follow-up period: Weeks 10 through 14
measure: Primary Outcome 3: Safety Monitoring: Biomedical measures - Pregnancy testing
timeFrame: Immediately prior to treatment intervention session (Week 5)
measure: Primary Outcome 3: Safety Monitoring: Biomedical measures - Heart Rate
timeFrame: Treatment intervention session (Week 5)
measure: Primary Outcome 3: Safety Monitoring: Biomedical measures - Blood Pressure
timeFrame: Treatment intervention session (Week 5)
Secondary outcomes:
measure: Feasibility Outcome 1: Attendance during study intervention.
timeFrame: Weeks 1-10
measure: Feasibility Outcome 2: Post-treatment intervention Qualitative Survey
timeFrame: End of treatment intervention period: Week 10
Other outcomes:
measure: Exploratory Outcome 1: Efficacy outcomes via self-report questionnaires: Adverse Childhood Events Questionnaire (ACE)
timeFrame: -28 to day 1 of programming (Week 0-1) and once again during Follow-up period (Weeks 10 through 14)
measure: Exploratory Outcome 2: Efficacy outcomes via self-report questionnaires: Patient Health Questionnaire - 9 (PHQ-9)
timeFrame: -28 to day 1 of programming (Week 0-1) and once again during Follow-up period (Weeks 10 through 14)
measure: Exploratory Outcome 3: Efficacy outcomes via self-report questionnaires: Generalized Anxiety Disorder - 7 (GAD-7)
timeFrame: -28 to day 1 of programming (Week 0-1) and once again during Follow-up period (Weeks 10 through 14)
measure: Exploratory Outcome 4: Efficacy outcomes via self-report questionnaires: McGill Quality of Life Questionnaire - Extended (MQOL-E)
timeFrame: -28 to day 1 of programming (Week 0-1) and once again during Follow-up period (Weeks 10 through 14)
measure: Exploratory Outcome 5: Efficacy outcomes via self-report questionnaires: Watts Connectedness Scale (WCS)
timeFrame: -28 to day 1 of programming (Week 0-1) and once again during Follow-up period (Weeks 10 through 14)
measure: Exploratory Outcome 6: Efficacy outcomes via self-report questionnaires: Substance Use & Coping Behaviours Questionnaire
timeFrame: -28 to day 1 of programming (Week 0-1) and once again during Follow-up period (Weeks 10 through 14)
Locations:
Study officials:
References: