Clinical TrialPalliative & End-of-Life DistressPsilocybinUnknown status

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

This Phase I interventional study (n=64) assesses feasibility of a resilience-focused 10-week community of practice programme incorporating one group-administered psilocybin-assisted therapy session for patients with end-of-life distress.

Target Enrollment
64 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

Single-group, early-phase study delivering a 10‑week research-informed community of practice (weekly 2‑hour sessions) with one mid-programme group psilocybin-assisted therapy session for patients with a terminal diagnosis and end-of-life distress.

Data collection focuses on feasibility and safety (biomedical measures during dosing, adverse events) and mental health impacts using quantitative questionnaires at baseline, during, immediately post-programme and at six months, plus qualitative surveys and exit interviews. Research data coordinated via REDCap hosted by Island Health.

Study Protocol

Preparation

10 sessions
120 min each

Dosing

1 sessions

Integration

sessions

Therapeutic Protocol

support

Study Arms & Interventions

Psilocybin group

experimental

Group-administered psilocybin-assisted therapy within a 10-week community of practice

Interventions

  • Psilocybin
    via Oral• single dose• 1 doses total

    One group-administered psilocybin session occurs midway through the 10-week programme; dose per local protocol.

Participants

Ages
19 – 80
Sexes
Male & Female

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.

Study Details

Locations

Canada

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