Actively Recruiting
Psilocybin Microdose for Psychological and Existential Distress in Palliative Care (PSYCHED-PAL-RCT)
Led by Bruyère Health Research Institute. · Updated on 2026-01-27
120
Participants Needed
7
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 remove the possibility that improvements in symptoms are only because patients thought they were getting treatment. We will enroll 120 patients from inpatient, outpatient, and community care settings across seven sites. Participants in the microdose psilocybin group will receive 2 or 3 mg of psilocybin daily, 4 days per week, for two consecutive weeks. The placebo group will receive placebo with the same treatment schedule. All participants will be offered microdose psilocybin after 2-week follow-up. If this study is successful, we have the potential to change how psychological distress is managed in patients with advanced illness.
CONDITIONS
Official Title
Psilocybin Microdose for Psychological and Existential Distress in Palliative Care (PSYCHED-PAL-RCT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older with advanced illness under palliative care and an estimated life expectancy of 2 to 12 months
- Experiencing psychological distress with a score of 7 or greater on the Edmonton Symptom Assessment System-revised (ESAS-r)
- Living in the community with outpatient or home palliative care, or in a chronic care inpatient facility with family able to assist medication
- Ability to understand and communicate in English or French
- For community patients, having another person present during and for 2 hours after taking the dose in the first week
You will not qualify if you...
- Current or past diagnosis of psychotic or bipolar disorder, or first-degree relative with these conditions
- Previously eligible for medical assistance in dying with intention to proceed regardless of study
- Delirium in past 3 months without reversible cause and resolution
- Moderate or severe dementia diagnosis
- Unable to provide informed consent personally
- Unable to complete assessments via telephone or video
- Severe or unstable physical symptoms per palliative care provider
- Palliative Performance Scale less than 50% (except in open-label phases)
- Cancer with known central nervous system involvement or other CNS disease
- Use of high-dose psychedelic substances in past year
- Taking lithium, tramadol, tapentadol, monoamine oxidase inhibitors, or atypical antipsychotics (with some exceptions)
- No available enteral route for drug administration
- Pregnancy or breastfeeding
AI-Screening
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Trial Site Locations
Total: 7 locations
1
William Osler Health System
Brampton, Ontario, Canada
Not Yet Recruiting
2
Providence Care Hospital
Kingston, Ontario, Canada
Actively Recruiting
3
St. Joseph's Healthcare
London, Ontario, Canada
Not Yet Recruiting
4
South Lake Regional Health Centre
Newmarket, Ontario, Canada
Actively Recruiting
5
Bruyere Health
Ottawa, Ontario, Canada
Actively Recruiting
6
The Ottawa Hospital
Ottawa, Ontario, Canada
Not Yet Recruiting
7
McGill University Health Centre
Montreal, Quebec, Canada
Not Yet Recruiting
Research Team
J
James Downar, MDCM, MHSc
CONTACT
J
Julie Lapenskie, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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