Oral CBD and THC for hip or knee osteoarthritis pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults aged 40–80 with ACR-diagnosed hip or knee osteoarthritis who meet entry criteria will take either a CBD capsule, a THC capsule, or a matching placebo each day for 8 weeks and complete remote follow-ups. Participants keep a diary of study drug use and any additional pain medications, and outcomes include pain interference measured with PROMIS-PI. There are no required in-person clinic visits for follow-up. The trial is a feasibility step to inform the design, dosing, and delivery of a larger randomized trial of medical cannabis for OA pain.

Why it matters

Who can join: the full rules

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

Where it's running

• University Health Network
  Toronto, Ontario, Canada Recruiting
• Women's College Hospital
  Toronto, Ontario, Canada Recruiting
• McGill University Health Centre/Montreal General Hospital
  Montreal, Quebec, Canada Recruiting

Study contacts

• Principal investigator: Dr. Hance Clarke, MD — University Health Network, Toronto
• Study coordinator: Sonal Thaker
• Email: sonalben.thaker@uhn.ca
• Phone: 1-416-340-4800

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.