A Community of Practice Program With... — Clinical Trial Details

Participants

Ages

19 – 80

Sexes

Male & Female

BMI

Psychosis History

Excluded

Inclusion Criteria

Inclusion Criteria:
Patient must have a terminal diagnosis with limited life expectancy (predicted life expectancy less than 2 years).
Ages 19–80 years.
Male, menopausal female, or if of childbearing potential not pregnant, using birth control and negative pregnancy test prior to psilocybin administration.
Ambulatory (Palliative Performance Status ≥50%).
eGFR >20 ml/min; AST <3x ULN and bilirubin <50 µmol/L.
Patient has emotional distress not successfully responded to other treatments (other treatments failed, not tolerated, inaccessible, or refused for acceptable reasons).
Patient demonstrates comprehension sufficient for understanding the consent form.

Exclusion Criteria

Exclusion Criteria:
Current participation in a clinical trial where psilocybin therapy would disqualify them from their primary treatment trial.
If female: pregnant (positive pregnancy test) or nursing.
Currently taking on a regular (e.g., daily) basis: investigational agents; MAO inhibitors; UGT modulators/inhibitors (UGT1A9/1A10); aldehyde or alcohol dehydrogenase inhibitors; SSRIs, SNRIs. Patients may be given option to wean off medications prior to psilocybin; MAO-A inhibitor washout minimum 2 weeks; MAO-B inhibitors assessed case-by-case with MRP oversight.
Known sensitivity or prior significant adverse reaction to psilocybin or related psychedelics.
Active uncontrolled epilepsy.
Uncontrolled cardiovascular conditions (uncontrolled hypertension, uncontrolled angina, clinically significant ECG abnormality e.g., QT prolongation).
Uncontrolled vascular disease (recent TIA/stroke with loss in mental status, peripheral/pulmonary vascular disease with active claudication).
Unstable insulin-dependent diabetes.
Cancer with central nervous system involvement, paraneoplastic syndromes, or tumours with ectopic hormone production that increase risk (e.g., hypercalcaemia, Cushing's, SIADH).
Psychiatric exclusions: severity of depression or anxiety requiring emergent treatment; current or past DSM-5 diagnosis confirmed by psychiatrist/psychologist of schizophrenia, psychotic disorder (unless substance-induced or medical), borderline personality disorder, bipolar I or II, dissociative disorder, or other conditions judged incompatible with safe exposure to psilocybin. Borderline personality disorder and bipolar disorders may be considered after psychiatric consultation.
Concurrent illicit drug use causing ongoing intoxication.
Unstable housing (homelessness).
First-degree relatives meeting DSM-5 criteria for bipolar disorder or schizophrenia.

Company

Product

Legal

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

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Therapeutic Protocol

Study Arms & Interventions

Psilocybin group

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators