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

Launched by THE ROOTS TO THRIVE SOCIETY FOR PSYCHEDELIC THERAPY · Jul 14, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new therapy for patients who are nearing the end of their lives and experiencing emotional distress. The study is called a Community of Practice Program, which means it involves a group of patients coming together for support and therapy over a 10-week period. One of the key components of this therapy is a session that includes psilocybin, a substance found in certain mushrooms that has been studied for its potential to help with anxiety and depression. The goal is to see if this approach can help improve the emotional well-being of patients facing terminal illnesses.

To participate in this trial, patients must have a terminal diagnosis, meaning their life expectancy is less than two years, and they should be between the ages of 19 and 80. They must also be experiencing emotional distress that hasn't improved with other treatments. Participants can expect to engage in group therapy with others in similar situations, where they will receive support and have the chance to experience psilocybin therapy in a safe environment. It’s important to note that certain medical conditions and medications may disqualify someone from joining the study, so a thorough evaluation will be conducted to ensure safety.

Gender

ALL

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