Cannabinoids for Osteoarthritis Pain Effectiveness Trial
The Effectiveness of Oral Cannabis Extracts for Osteoarthritic Pain: an Internal Pilot, Placebo Controlled, Blinded Randomized Trial
University Health Network, Toronto
100 participants
Jan 29, 2026
INTERVENTIONAL
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 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 additional pain medications
Eligibility
Inclusion Criteria5
- 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 Criteria16
- 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
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Interventions
The starting dose will be 1 capsule per day (50 mg CBD) taken orally. The dose will be gradually increased over the first four weeks, based on patient assessment, up to a maximum of five capsules per day (250 mg CBD) in divided doses. Once the dose that maximizes potential therapeutic effects while minimizing adverse effects has been determined, it will be maintained for the remaining four weeks of the trial.
The starting dose will be 1 capsule per day (3 mg THC) taken orally. The dose will be gradually increased over the first four weeks, based on patient assessment, up to a maximum of five capsules per day (15 mg THC) in divided doses. Once the dose that maximizes potential therapeutic effects while minimizing adverse effects has been determined, it will be maintained for the remaining four weeks of the trial.
The starting dose will be 1 capsule per day taken orally. The dose will be gradually increased over the first four weeks, based on patient assessment, up to a maximum of five capsules per day in divided doses. Once the dose that maximizes potential therapeutic effects while minimizing adverse effects has been determined, it will be maintained for the remaining four weeks of the trial.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06878417