A Community of Practice Program With Psilocybin-assisted Therapy for End-of-Life Patients

NCT05958758 | Unknown Early Phase 1 DMC

• 1 other identifier: H22-02523
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

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.

Conditions

End of Life

Outcome Measures

Primary Outcomes (5)

• Primary Outcome 1: Treatment Intervention Phase - Safety Monitoring: Adverse events (AEs), serious adverse events (SAEs) and treatment emergent adverse events (TEAEs)

  Safety in the trial will be evaluated by monitoring AEs, SAEs, and TEAEs over the 10-week intervention period. Adverse events will be defined and documented according to the adverse reporting procedures and be collected via self-report, report from others, or chart abstraction.

  Treatment intervention period: Weeks 1 through 10

• Primary Outcome 2: Follow-up to Treatment Phase - Safety Monitoring: Adverse events (AEs), serious adverse events (SAEs) and treatment emergent adverse events (TEAEs)

  Safety in the trial will be evaluated by monitoring AEs, SAEs, and TEAEs during the 30-day treatment intervention follow-up phase. Adverse events will be defined and documented according to the adverse reporting procedures and be collected via self-report, report from others, or chart abstraction.

  Follow-up period: Weeks 10 through 14

• Primary Outcome 3: Safety Monitoring: Biomedical measures - Pregnancy testing

  A urine pregnancy test measuring beta-human chorionic gonadotropin (B-hCG) will be conducted on the pre-treatment targeted physical exam visit to ensure the participant is not pregnant. If the pregnancy test is positive, the participant will be unable to participate in the treatment intervention at Week 5 but will be invited to remain in group therapy interventions sessions (Weeks 1-10).

  Immediately prior to treatment intervention session (Week 5)

• Primary Outcome 3: Safety Monitoring: Biomedical measures - Heart Rate

  Vitals signs, including heart rate (beats per minute/BPM) will be measured before, during, and after the treatment intervention session.

  Treatment intervention session (Week 5)

• Primary Outcome 3: Safety Monitoring: Biomedical measures - Blood Pressure

  Vitals signs, including blood pressure (millimeters of mercury/mmHg) will be measured before, during, and after the treatment intervention session.

  Treatment intervention session (Week 5)

Secondary Outcomes (2)

• Feasibility Outcome 1: Attendance during study intervention.

  Weeks 1-10

• Feasibility Outcome 2: Post-treatment intervention Qualitative Survey

  End of treatment intervention period: Week 10

Other Outcomes (6)

• Exploratory Outcome 1: Efficacy outcomes via self-report questionnaires: Adverse Childhood Events Questionnaire (ACE)

  -28 to day 1 of programming (Week 0-1) and once again during Follow-up period (Weeks 10 through 14)

• Exploratory Outcome 2: Efficacy outcomes via self-report questionnaires: Patient Health Questionnaire - 9 (PHQ-9)

  -28 to day 1 of programming (Week 0-1) and once again during Follow-up period (Weeks 10 through 14)

• Exploratory Outcome 3: Efficacy outcomes via self-report questionnaires: Generalized Anxiety Disorder - 7 (GAD-7)

  -28 to day 1 of programming (Week 0-1) and once again during Follow-up period (Weeks 10 through 14)

Study Arms (1)

Single arm

EXPERIMENTAL

Group administered Psilocybin-assisted therapy

Drug: Psilocybin-assisted therapy within a community of practice model (group administered)

Interventions

Psilocybin-assisted therapy within a community of practice model (group administered) DRUG

The community of practice is 10 weeks long, meeting virtually for 2 hours each week, in a structured process, run through the Roots to Thrive treatment program. The psilocybin-assited therapy sessions occur midway through the 10-week program.

Single arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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:

Sponsors & Collaborators

• The Roots to Thrive Society for Psychedelic Therapy: lead
• Vancouver Island Health Authority: collaborator
• Vancouver Island University: collaborator

MeSH Terms

Conditions

Death

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: July 25, 2023
• Study Start: September 1, 2023
• Primary Completion: April 30, 2025
• Study Completion: October 31, 2025
• Last Updated: July 25, 2023

Record last verified: 2023-07