Cannabinoids for Osteoarthritis

(COPE Trial)

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether cannabis extracts, specifically CBD and THC, can help manage pain from osteoarthritis, a common joint issue. Many people with osteoarthritis experience pain that current options struggle to treat effectively, so researchers are comparing these cannabis compounds to a placebo. Individuals with moderate to severe hip or knee pain due to osteoarthritis, who haven't recently started new pain treatments, might find this trial suitable. Participants will take daily capsules for 8 weeks and track their pain and medication use from home. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on alternative pain management options.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that CBD (Cannabidiol) is generally safe and well-tolerated in low doses, under 60 mg per day. Most people did not experience serious side effects. However, concerns exist about possible liver damage or fertility issues with CBD, though these are not often reported.

For THC (∆9-tetrahydrocannabinol), limited information is available on its safety for treating osteoarthritis. Some research suggests it can alter mood or perception, but these effects might lessen when used with CBD. More research is needed to fully understand THC's safety for osteoarthritis pain.

Both CBD and THC are under study for their potential to help manage pain, but these findings rely on earlier studies and ongoing research. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike traditional treatments for osteoarthritis, which often include NSAIDs or corticosteroids to manage pain and inflammation, the treatments in this trial use cannabinoids like CBD (Cannabidiol) and THC (∆9-tetrahydrocannabinol). CBD is known for its anti-inflammatory properties without the psychoactive effects associated with THC, while THC might offer pain relief by interacting with the body's endocannabinoid system. Researchers are excited about these treatments because they offer a new approach by potentially reducing pain and inflammation through natural compounds found in cannabis, which could provide an alternative for patients who experience side effects from conventional medications.

What evidence suggests that this trial's treatments could be effective for osteoarthritis?

This trial will compare the effects of CBD (Cannabidiol) and THC (∆9-tetrahydrocannabinol) on osteoarthritis pain. Studies have shown that CBD can reduce osteoarthritis pain, with one study reporting a 44% reduction. Another study found that CBD could lower joint inflammation and pain. However, some research found no significant effect on pain when CBD was used with other painkillers.

For THC, research suggests it might relieve pain. One study reported nearly a 39% decrease in pain with THC use, but other studies showed only slight improvements. The evidence for both CBD and THC is promising but mixed, so more research is needed to fully understand their effectiveness for osteoarthritis pain. Participants in this trial will receive either CBD, THC, or a placebo to further investigate these effects. ^{2 6 7 8 9}

Who Is on the Research Team?

Dr. Hance Clarke, MD

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9400326/

Cannabidiol as a treatment for arthritis and joint pain The overall cohort reported a 44% reduction in pain after CBD use (P<0.001). The osteoarthritis group had a greater percentage reduction (P= ...

2. jbjs.org jbjs.org/reader.php?rsuite_id=2994463

Efficacy of Cannabidiol in Treating Osteoarthritis Results: The ability of CBD to reduce acute OA synovitis, reduce neuropathic joint pain, and prevent the progression of OA pain has resulted in increased ...

3. nature.com nature.com/articles/s41598-024-62428-x

An open-label feasibility trial of transdermal cannabidiol for ... The current study suggests that transdermal CBD gel may have a beneficial effect on pain and grip strength in participants with symptomatic hand ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06878417

Cannabinoids for Osteoarthritis Pain Effectiveness Trial This study aims to investigate whether oral cannabis extracts can effectively manage pain caused by osteoarthritis (OA), a common joint condition affecting one ...

5. thelancet.com thelancet.com/journals/lanepe/article/PIIS2666-7762(23)00196-5/fulltext

Oral cannabidiol (CBD) as add-on to paracetamol for ... A placebo-controlled trial in hand osteoarthritis and psoriatic arthritis found no significant effect of CBD on pain intensity. 14.

6. arthritis.org arthritis.org/health-wellness/healthy-living/managing-pain/pain-relief-solutions/cbd-for-arthritis-pain

CBD for Arthritis Pain: What You Should Know So far, no serious safety concerns have been associated with moderate doses, but CBD may cause liver damage or fertility issues. It also has the potential to ...

7. tga.gov.au tga.gov.au/sites/default/files/review-safety-low-dose-cannabidiol.pdf

Safety of low dose cannabidiol The review found that cannabidiol presents a good safety and tolerability profile at the low dose range of under 60mg/day. • The review identified that ...

8. frontiersin.org frontiersin.org/journals/veterinary-science/articles/10.3389/fvets.2018.00165/full

Pharmacokinetics, Safety, and Clinical Efficacy of ... This pharmacokinetic and clinical study suggests that 2 mg/kg of CBD twice daily can help increase comfort and activity in dogs with OA.

9. health.harvard.edu health.harvard.edu/blog/cannabidiol-cbd-what-we-know-and-what-we-dont-201808242496

Cannabidiol (CBD): What we know and what we don't One animal study from the European Journal of Pain suggests CBD could help lower pain and inflammation due to arthritis when applied to skin.