Oral CBD and THC for hip or knee osteoarthritis pain

The Effectiveness of Oral Cannabis Extracts for Osteoarthritic Pain: an Internal Pilot, Placebo Controlled, Blinded Randomized Trial

This study will test whether taking a daily oral CBD or THC capsule can reduce pain interference in adults aged 40–80 with hip or knee osteoarthritis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: University Health Network, Toronto (Academic / other)
• Locations: 3 sites (Toronto, Ontario and 2 other locations)
• Trial ID: NCT06878417 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 40–80 years old with hip and/or knee osteoarthritis by ACR criteria, a PROMIS-PI SF-6a T-score ≥60, no recent changes to analgesics or OA treatments, able to self-report in English or French, and without recent cannabis use or contraindications are ideal candidates.

Not a fit: People with inflammatory arthritis, planned joint surgery or recent/planned joint injections, recent cannabis use or a history of cannabis use disorder, or contraindications to cannabinoids are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, one or both cannabinoids could provide an additional option to reduce pain interference and improve daily function for people with hip or knee osteoarthritis.

How similar studies have performed: Prior small or low-quality studies of cannabinoids for chronic noncancer musculoskeletal pain have shown mixed or modest effects, so benefit for OA pain remains unproven.

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

Where this trial is running

Toronto, Ontario and 2 other locations

• 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 (Not_yet_recruiting)

Study contacts

• Principal investigator: Dr. Hance Clarke, MD — University Health Network, Toronto
• Study coordinator: Sonal Thaker

Conditions Osteoarthritis of Knee; Osteoarthritis Hip; Medical Cannabis