Condition: Psychological Distress · Sponsor: Bruyère Health Research Institute.
About 30-50% of patients with advanced illness experience depression, anxiety, or decreased sense of purpose and autonomy. Together, these are called psychological distress. Treatment options such as medication and therapy are available; however, they do not always work and can be time-consuming and expensive. We need treatments that work well, quickly, and can be available to all patients with advanced illness who have psychological distress. Psilocybin, a psychedelic medication (commonly called 'magic mushrooms') works well for improving psychological distress in people with cancer or chronic illness when given in high doses with specific forms of therapy. However, psilocybin has not been well-studied among people with advanced illness, and there are concerns about safety and side effects in people approaching the end of life. However, reports on psilocybin microdosing, which involves taking small doses that do not cause hallucinations and do not require therapy, suggest that this may be effective, safer, and more acceptable for people with advanced illness. We recently completed a small study of psilocybin microdosing. Our results showed psilocybin microdose improved psychological distress in most participants with advanced illness, without serious side effects. Our next step is to do a randomized clinical trial where some patients receive psilocybin microdose and some receive placebo (a drug that contains no medicinal ingredients). By comparing these two groups, we can …
This description comes directly from the study's public registry record.
James Downar, MDCM, MHSc · 613-562-6262 · jdownar@toh.ca
Julie Lapenskie, MSc · 613-562-6262 · jlapenskie@bruyere.org
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| William Osler Health System | Brampton, Ontario, Canada | Not Yet Recruiting |
| Providence Care Hospital | Kingston, Ontario, Canada | Recruiting |
| St. Joseph's Healthcare | London, Ontario, Canada | Not Yet Recruiting |
| South Lake Regional Health Centre | Newmarket, Ontario, Canada | Recruiting |
| Bruyere Health | Ottawa, Ontario, Canada | Recruiting |
| The Ottawa Hospital | Ottawa, Ontario, Canada | Not Yet Recruiting |
| McGill University Health Centre | Montreal, Quebec, Canada | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT07063862