Psilocybin for Psychological and Existential Distress in Palliative Care

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.

Topic Depression Anxiety Palliative Care Microdosing
Compound Psilocybin
Country Canada
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 August 2021
End date 01 January 2023
Phase Phase I Phase II
Design Open
Type Interventional
Generation First
Participants 40
Sex All
Age 18- 99
Therapy Yes

Trial Details

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.

Trial Number NCT04754061

Sponsors & Collaborators

Ottawa Hospital Research Institute
The Otawa Hospital Research Institute has sponsored a clinical trial with psilocybin.

University of Ottawa
The University of Ottawa launched  The Psychedelics & Spirituality Studies Initiative (PSSI) in 2021. PSSI is an interdisciplinary group of faculty and graduate students who share a common interest in the study of psychedelics, spirituality and integrative healing.

The Ottawa Hospital
The Ottawa Hospital will serve as a test site in an upcoming trial with psilocybin.

Bruyere Research Institute
The Bruyere Research Institutewill serve as a test site in an upcoming trial with psilocybin.

CHU de Quebec-Universite Laval
CHU de Quebec-Universite Laval will serve as a test site in an upcoming trial with psilocybin.

St. Joseph's Healthcare Hamilton
St. Joseph's Healthcare Hamilton is an academic hospital that will serve as test site in a upcoming trial with psilocybin.

Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke
Centre de recherche du CHUS will serve as a test site in an upcoming trial with psilocybin.

Jewish General Hospital
Jewish General Hospital will serve as a test site in an upcoming trial with psilocybin.

William Osler Health System
Hospitals in the William Osler network will serve as test sites for a trial with psilocybin.

Kingston Health Sciences Centre
Kingston Health Sciences Centre will serve as a test site in an upcoming trial with psilocybin.

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.