Status:
NOT_YET_RECRUITING
Cannabinoids for Osteoarthritis Pain Effectiveness Trial
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Osteoarthritis of Knee
Osteoarthritis Hip
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
This study aims to investigate whether oral cannabis extracts can effectively manage pain caused by osteoarthritis (OA), a common joint condition affecting one in seven Canadians. Current OA treatment...
Detailed Description
The rationale for this study lies in the significant impact of osteoarthritis (OA) on individuals and society, coupled with the limited effectiveness and potential side effects of current treatments. ...
Eligibility Criteria
Inclusion
- Age 40-80 years
- Diagnosed with hip and/or knee osteoarthritis as per the American College of Rheumatology criteria
- Experiencing moderate to severe pain interference as indicated by a PROMIS-PI SF-6a T-score ≥ 60
- Have not initiated any new analgesics or osteoarthritis treatments in the previous 4 weeks
- Able to self-report, understand and read English or French
Exclusion
- Hip or knee surgery planned in the coming 4 months,
- Injection into the affected joint(s) within the past 3 months (e.g., cortisone, plasma-rich protein, etc.),
- Planned injection into the affected joint(s) during trial period,
- Inflammatory arthritis (e.g., rheumatoid arthritis, Psoriatic arthritis, gout, etc.),
- Contraindications to taking cannabis/cannabinoids,
- Used nabilone or nabiximols in the last 30 days,
- Used cannabis (medical or recreational) in the last 30 days (to allow sufficient washout),
- A history of diagnosed cannabis use disorder or dependence,
- Active substance use disorder,
- Current DSM-V diagnosis of bipolar disorder, major depression, or psychosis,
- An uncontrolled medical or major psychiatric disorder,
- Currently on warfarin,
- Known pregnancy or currently breastfeeding,
- Men and women planning a pregnancy during the study or in the 12 weeks after stopping IPs
- No fixed address or a plan to change addresses in the coming 4 months,
- Known or suspected allergy to palm/coconut oil
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06878417
Start Date
December 1 2025
End Date
December 31 2026
Last Update
November 18 2025
Active Locations (3)
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1
University Health Network
Toronto, Ontario, Canada, M5G 2C4
2
Women's College Hospital
Toronto, Ontario, Canada, M5S 1B2
3
McGill University Health Centre/Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4