Cannabinoids for Osteoarthritis

(COPE Trial)

Recruiting at 2 trial locations

Overseen By Deep Grewal

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Must not be taking: Warfarin, Nabilone, Nabiximols, Cannabis

Disqualifiers: Inflammatory arthritis, Bipolar, Depression, Psychosis, others

Compensation: Varies

Number of Visits: 11

Duration: 8 weeks

100 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot have started any new pain or osteoarthritis treatments in the last 4 weeks. Also, you cannot be on warfarin or have used cannabis in the last 30 days.

What data supports the effectiveness of the drug Cannabis Extracts for osteoarthritis?

Research suggests that cannabinoids, the active components in cannabis, may help manage pain associated with osteoarthritis by interacting with the body's endocannabinoid system, which plays a role in pain and inflammation. While there is strong evidence from animal studies showing cannabinoids can reduce pain, more human clinical trials are needed to confirm their effectiveness for osteoarthritis specifically. ^{1 2 3 4 5}

Is it safe to use cannabinoids for osteoarthritis?

The research articles provided do not contain specific safety data on cannabinoids for osteoarthritis or other conditions. ^{6 7 8 9 10}

How does the drug Cannabis Extracts differ from other treatments for osteoarthritis?

Cannabis Extracts are unique because they contain a high ratio of cannabidiol (CBD) to tetrahydrocannabinol (THC), which may reduce inflammation and joint damage without the psychoactive effects typically associated with THC. This drug works by interacting with cannabinoid receptors to potentially protect cartilage and reduce inflammation, offering a novel approach compared to traditional anti-inflammatory medications. ^{11 12 13 14 15}

What is the purpose of this trial?

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

Research Team

Dr. Hance Clarke, MD

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

This trial is for individuals with osteoarthritis, specifically in the hip or knee. Participants will take a daily capsule of either CBD, THC, or a placebo for 8 weeks and track their pain medication use. The study requires remote follow-ups.

Inclusion Criteria

I experience significant pain that affects my daily activities.

I haven't started any new pain or arthritis treatments in the last month.

I can read, understand, and speak English or French.

Exclusion Criteria

A history of diagnosed cannabis use disorder or dependence

Active substance use disorder

Used cannabis (medical or recreational) in the last 30 days (to allow sufficient washout)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either CBD, THC, or placebo capsules daily for 8 weeks

8 weeks

Remote follow-ups at weeks 1, 2, 3, 4, 6, and 8

Follow-up

Participants are monitored for safety and effectiveness after treatment, including support for tapering off investigational products

4 weeks

Scheduled follow-ups at the end of weeks 10 and 12

Treatment Details

Interventions

• Cannabis Extracts

Trial Overview The study tests the effectiveness of oral cannabis extracts (CBD and THC) versus a placebo in managing osteoarthritis pain. It aims to determine if these treatments can be alternatives to current options with limited success and side effects.

Participant Groups

Group I: THC (∆9-tetrahydrocannabinol) Experimental Treatment 1 Intervention

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

Group II: CBD (Cannabidiol) Experimental Treatment 1 Intervention

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

Group III: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

References

1. France pubmed.ncbi.nlm.nih.gov

Involvement of the endocannabinoid system in osteoarthritis pain. [2014]

2. England pubmed.ncbi.nlm.nih.gov

Cannabinoids and pain. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

International Association for the Study of Pain Presidential Task Force on Cannabis and Cannabinoid Analgesia: research agenda on the use of cannabinoids, cannabis, and cannabis-based medicines for pain management. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review of Medical Cannabinoids Dosing in Human. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

The therapeutic effects of Cannabis and cannabinoids: An update from the National Academies of Sciences, Engineering and Medicine report. [2018]

6. Italy pubmed.ncbi.nlm.nih.gov

Nutraceuticals for the treatment of osteoarthritis. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Recent developments in the treatment of osteoarthritis with NSAIDs. [2019]

8. Ireland pubmed.ncbi.nlm.nih.gov

A prospective, randomized, double-blind, multicenter comparative study on the safety and efficacy of Celecoxib and GCSB-5, dried extracts of six herbs, for the treatment of osteoarthritis of knee joint. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Joint problems arising from lack of repair mechanisms: can cannabinoids help? [2021]

10. England pubmed.ncbi.nlm.nih.gov

Randomised clinical trial: gastrointestinal events in arthritis patients treated with celecoxib, ibuprofen or naproxen in the PRECISION trial. [2019]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Immunosuppressive activity of non-psychoactive Cannabis sativa L. extract on the function of human T lymphocytes. [2022]

12. Switzerland pubmed.ncbi.nlm.nih.gov

THC-Reduced Cannabis sativa L.-How Does the Solvent Determine the Bioavailability of Cannabinoids Given Orally? [2023]

13. United States pubmed.ncbi.nlm.nih.gov

The heterogeneity and complexity of Cannabis extracts as antitumor agents. [2020]

14. Switzerland pubmed.ncbi.nlm.nih.gov

Valorization of Wild-Type Cannabis indica by Supercritical CO2 Extraction and Insights into the Utilization of Raffinate Biomass [2023]

15. England pubmed.ncbi.nlm.nih.gov

Cannabinoids: novel therapies for arthritis? [2012]