Sponsor: Ottawa Hospital Research Institute

Collaborators: Bruyere Research Institute, The Ottawa Hospital, St. Joseph’s Healthcare Hamilton, CHU de Quebec-Universite Laval, Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Jewish General Hospital, William Osler Health System ,Kingston Health Sciences Centre

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Brief Summary: The goal of this multi-centre phase I/II open-label, single-arm study is to determine the safety, feasibility, therapeutic dose, and preliminary efficacy of psilocybin microdosing to treat psychological distress among patients with advanced illness. Forty patients will receive psilocybin drug product (1-3mg per day, Mon-Fri) for 4 weeks to be administered via oral capsules by the participant. Feasibility (recruitment rate, rate of intervention and follow-up completion), safety (rate of adverse events), dosing, and preliminary efficacy (depression, anxiety, overall well-being, and global impression of change) will be measured.

Inclusion Criteria:

  1. Patients >/=18 years of age
  2. Advanced illness under palliative care management, defined as having 1 to <12 months life expectancy (in the judgment of the palliative care provider)
  3. Experiencing psychological distress, defined as a score of 7 or greater on the Depression, Anxiety or Well-being item of the Edmonton Symptom Assessment System
  4. Ability to understand and communicate in English or French

Content retrieved from https://clinicaltrials.gov/ (NCT number): NCT04754061

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