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Cannabinoids for Osteoarthritis Pain Effectiveness Trial

RecruitingNAAges 40 Years - 80 YearsAllUniversity Health Network, Toronto
NCT06878417 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 treatments often have limited effectiveness and may cause side effects. As a result, many individuals with OA turn to medical cannabis for pain relief, despite limited scientific evidence supporting its efficacy. The goal of this study is to assess the feasibility of a larger trial evaluating the effects of two cannabis compounds-CBD and THC-compared to a placebo (a look-alike substance containing no active drug) on pain interference in patients with hip and/or knee osteoarthritis. Participants will: * Take either CBD, THC, or a placebo capsule daily for 8 weeks * Complete follow-ups remotely, with no in-person clinic visits required * Maintain a diary tracking their study drug usage and any addit

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📋 Eligibility rules (as published)
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
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What it tests

  • CBD
  • THC
  • Placebo
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Where

3 sites
University Health Network
Toronto, Canada
Women's College Hospital
Toronto, Canada
McGill University Health Centre/Montreal General Hospital
Montreal, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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