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Unknown statusEarly Phase 1

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

NCT05958758 · The Roots to Thrive Society for Psychedelic Therapy

Closed to entry
Status
Not accepting participants
Early Phase 1
Phase
64
Target enrolment
Study sites

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

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

    Measured over 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)

    Measured over Follow-up period: Weeks 10 through 14

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

    Measured over Immediately prior to treatment intervention session (Week 5)

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

    Measured over Treatment intervention session (Week 5)

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

    Measured over Treatment intervention session (Week 5)

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

19 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05958758 on ClinicalTrials.gov →

Last updated in the registry 2023-07-25. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance