Cannabinoids for Osteoarthritis Pain Effectiveness Trial
Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Mar 12, 2025
Trial Information
Current as of April 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
The Cannabinoids for Osteoarthritis Pain Effectiveness Trial is studying whether oral cannabis extracts can help manage pain from osteoarthritis, a common joint condition that affects many Canadians. The trial will compare two cannabis compounds, CBD and THC, with a placebo (a fake treatment with no active ingredients) to see how they affect pain in people with hip or knee osteoarthritis. This research is important because current treatments often don't work well and can have side effects, leading some people to try medical cannabis for relief.
To participate, individuals should be between 40 and 80 years old and have been diagnosed with hip or knee osteoarthritis. They should be experiencing moderate to severe pain and not have started any new pain medications in the past month. Participants will take a capsule daily for 8 weeks, either the cannabis extract or the placebo, and will not need to visit a clinic in person, as follow-ups will be done remotely. It's important for potential participants to know that there are specific health criteria that could exclude them, such as recent surgeries or certain medical conditions.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Age 40-80 years
- • 2. Diagnosed with hip and/or knee osteoarthritis as per the American College of Rheumatology criteria
- • 3. Experiencing moderate to severe pain interference as indicated by a PROMIS-PI SF-6a T-score ≥ 60
- • 4. Have not initiated any new analgesics or osteoarthritis treatments in the previous 4 weeks
- • 5. Able to self-report, understand and read English or French
- Exclusion Criteria:
- • 1. Hip or knee surgery planned in the coming 4 months,
- • 2. Injection into the affected joint(s) within the past 3 months (e.g., cortisone, plasma-rich protein, etc.),
- • 3. Planned injection into the affected joint(s) during trial period,
- • 4. Inflammatory arthritis (e.g., rheumatoid arthritis, Psoriatic arthritis, gout, etc.),
- • 5. Contraindications to taking cannabis/cannabinoids,
- • 6. Used nabilone or nabiximols in the last 30 days,
- • 7. Used cannabis (medical or recreational) in the last 30 days (to allow sufficient washout),
- • 8. A history of diagnosed cannabis use disorder or dependence,
- • 9. Active substance use disorder,
- • 10. Current DSM-V diagnosis of bipolar disorder, major depression, or psychosis,
- • 11. An uncontrolled medical or major psychiatric disorder,
- • 12. Currently on warfarin,
- • 13. Known pregnancy or currently breastfeeding,
- • 14. Men and women planning a pregnancy during the study or in the 12 weeks after stopping IPs
- • 15. No fixed address or a plan to change addresses in the coming 4 months,
- • 16. Known or suspected allergy to palm/coconut oil
About University Health Network, Toronto
University Health Network (UHN), based in Toronto, is a leading academic health sciences center dedicated to advancing patient care through innovative research and education. As a prominent sponsor of clinical trials, UHN integrates cutting-edge scientific discoveries with clinical practice, facilitating the development of new therapies and treatment modalities. With a commitment to improving health outcomes, UHN collaborates with a diverse network of researchers, healthcare professionals, and industry partners, fostering an environment that prioritizes patient safety and ethical standards in clinical research. Through its extensive resources and expertise, UHN plays a pivotal role in transforming healthcare and enhancing the quality of life for patients both locally and globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Patients applied
Trial Officials
Dr. Hance Clarke, MD
Principal Investigator
University Health Network, Toronto
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported