Actively Recruiting
PSilocybin for psYCHological and Existential Distress in PALliative Care (PSYCHED-PAL)
Led by Ottawa Hospital Research Institute · Updated on 2024-08-09
20
Participants Needed
2
Research Sites
72 weeks
Total Duration
On this page
Sponsors
O
Ottawa Hospital Research Institute
Lead Sponsor
B
Bruyère Health Research Institute.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PSilocybin for psYCHological and Existential Distress in PALliative Care (PSYCHED-PAL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age or older
- Advanced illness under palliative care with 1 to less than 12 months life expectancy
- Experiencing psychological distress with a score of 7 or greater on the Depression, Anxiety or Well-being item of the Edmonton Symptom Assessment System
- Ability to understand and communicate in English or French
You will not qualify if you...
- Current or past diagnosis of psychotic or bipolar disorder, or first-degree relative with these conditions
- Previously approved for medical assistance in dying with intention to proceed regardless of study
- Documented or suspected delirium in the past 3 months without clear reversible cause and resolution
- Moderate or severe dementia diagnosis
- Unable to provide informed consent
- Severe or unstable physical symptoms per palliative care provider
- Palliative Performance Scale below 30%
- Cancer with known central nervous system involvement or other CNS disease
- Use of high-dose psychedelic substances in the past year
- Taking lithium at any dose
- Taking tramadol at any dose
- Taking any monoamine oxidase inhibitor
- Taking atypical antipsychotics unless stopped or substituted with haloperidol 48 hours before and during intervention
- Unable to swallow oral capsules
- Pregnancy or breastfeeding
- Must not take other psychedelic substances during trial and follow-up
- Must not take benzodiazepines or antipsychotics within 12 hours of psilocybin dose
- Stable dose and approval required if taking SSRIs or antipsychotics
AI-Screening
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Trial Site Locations
Total: 2 locations
1
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
2
Bruyere Continuing Care
Ottawa, Ontario, Canada, K1R 6K9
Actively Recruiting
Research Team
J
James Downar, MDCM, MSc
CONTACT
J
Julie Lapenskie, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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