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

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