Health TrialsbyHealthPanel

Cannabinoids for Osteoarthritis Pain Effectiveness Trial

ConditionsOsteoarthritis of KneeOsteoarthritis Hip
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorUniversity Health Network, Toronto

About 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 40-80 years

Diagnosed with hip and/or knee osteoarthritis as per the American College of Rheumatology criteria

Experiencing moderate to severe pain interference as indicated by a PROMIS-PI SF-6a T-score ≥ 60

Have not initiated any new analgesics or osteoarthritis treatments in the previous 4 weeks

Disqualifiers

Hip or knee surgery planned in the coming 4 months,

Injection into the affected joint(s) within the past 3 months (e.g., cortisone, plasma-rich protein, etc.),

Planned injection into the affected joint(s) during trial period,

Inflammatory arthritis (e.g., rheumatoid arthritis, Psoriatic arthritis, gout, etc.),

Trial design

Design model

Parallel

Treatments tested in this trial

  • CBD

    Drug

    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

    Drug

    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

    Drug

    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.

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: CBD (Cannabidiol)Experimental treatment 1 intervention
Group B: THC (∆9-tetrahydrocannabinol)Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility outcome: pertaining to the enrollment rate

Percentage of eligible and interested patients enrolled

Time frame
Through study completion, an average of 1 year
2

Feasibility outcome: pertaining to the Protocol adherence

Percentage of participants with no major protocol deviation (i.e., no concomitant cannabis use or initiation of new OA treatment)

Time frame
Up to 8 weeks post-treatment
3

Feasibility outcome: pertaining to data completeness

Percentage of enrolled participants with complete PROMIS Pain Interference data at 8 weeks

Time frame
Up to 8 weeks post-treatment

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Source ClinicalTrials.gov
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