Cannabinoids for Osteoarthritis Pain Effectiveness Trial
Recruiting · NCT06878417 · Interventional (participants receive a specific treatment) · Lead sponsor: University Health Network, Toronto
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
Inclusion criteria
- 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 criteria
- 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
Where it is running
3 locations listed.
- University Health Network - Toronto, Ontario, Canada
- Women's College Hospital - Toronto, Ontario, Canada
- McGill University Health Centre/Montreal General Hospital - Montreal, Quebec, Canada