Recruiting

CBD & THC

Sponsor:

University Health Network, Toronto

Code:

NCT06878417

Conditions

Osteoarthritis of Knee

Osteoarthritis Hip

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

CBD

THC

Placebo

Study Details

Brief 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

Conditions

Osteoarthritis of Knee

Osteoarthritis Hip

Study ID

NCT06878417

Start date

Jan 29, 2026

Status verified date

Jun, 2026

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: CBD (Cannabidiol)

Each capsule contains a concentration of 50 mg of Cannabidiol (CBD). Participants will receive CBD for a total duration of 8 weeks.

experimental: THC (∆9-tetrahydrocannabinol)

Each capsule contains a concentration of 3 mg of ∆9-tetrahydrocannabinol (THC). Participants will receive THC capsules for a total duration of 8 weeks.

placebo comparator: Placebo

Participants will receive matching placebo capsules for a total duration of 8 weeks.

Interventions

CBD

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.

THC

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.

Placebo

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.

Primary outcome measure

  • Feasibility outcome: pertaining to the enrollment rate [ Time Frame: Through study completion, an average of 1 year ]
  • Feasibility outcome: pertaining to the Protocol adherence [ Time Frame: Up to 8 weeks post-treatment ]
  • Feasibility outcome: pertaining to data completeness [ Time Frame: Up to 8 weeks post-treatment ]

Central Contacts and Locations

Central contacts

Sonal Thaker

1-416-340-4800sonalben.thaker@uhn.ca

Deep Grewal

1-416-340-4800Deep.Grewal@uhn.ca

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Mary Nasim

1-416-603-5800Mary.nasim@uhn.ca

Principal Investigator:

Dr. Hance Clarke, MD

Women's College Hospital

Recruiting

Toronto, Ontario, Canada, M5S 1B2

Contacts

Didem Bozak

1-(416)-323-6008Didem.Bozak@wchospital.ca

Principal Investigator:

Dr. Karim Ladha, MD

McGill University Health Centre/Montreal General Hospital

Recruiting

Montreal, Quebec, Canada, H3G 1A4

Contacts

Tanya Capolicchio

1-514-934-1934tanya.capolicchio@rimuhc.ca

Principal Investigator:

Dr. Mary-Ann Fitzcharles, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jul 16, 2026

Last verified

Jun, 2026

Keywords

  • Medical Cannabis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-16. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-07-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.