Psilocybin for Psychological and Existential Distress in Palliative Care
Status:
Not yet recruiting
Trial end date:
2023-01-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborators:
Bruyere Research Institute Centre de recherche du Centre hospitalier universitaire de Sherbrooke CHU de Quebec-Universite Laval Jewish General Hospital Kingston Health Sciences Centre St. Joseph's Healthcare Hamilton The Ottawa Hospital William Osler Health System