Testing CBD against a placebo for osteoarthritis of knee
Official title: Cannabinoids for Osteoarthritis Pain Effectiveness Trial
The Effectiveness of Oral Cannabis Extracts for Osteoarthritic Pain: an Internal Pilot, Placebo Controlled, Blinded Randomized Trial
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.
Canadian Sites (3)
University Health Network
Toronto, Ontario, Canada
Women's College Hospital
Toronto, Ontario, Canada
McGill University Health Centre/Montreal General Hospital
Montreal, Quebec, Canada
Eligibility Criteria
See who this study is looking for21 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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-PIPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → SF-6a T-score ≥ 60
- +Have not initiated any new analgesics or osteoarthritis treatments in the previous 4 weeks
- +Able to self-report, understand and read English or French
Exclusion
- −Known or suspected allergy to palm/coconut oil
- −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.),
- −Contraindications to taking cannabis/cannabinoids,
- −Used nabilone or nabiximols in the last 30 days,
- −Used cannabis (medical or recreational) in the last 30 days (to allow sufficient washoutWashout periodA gap with no treatment, so the previous one clears your system.Read more →),
- −A history of diagnosed cannabis use disorder or dependence,
- −Active substance use disorder,
- −Current DSM-V diagnosis of bipolar disorder, major depression, or psychosis,
- −An uncontrolled medical or major psychiatric disorder,
- −Currently on warfarin,
- −No fixed address or a plan to change addresses in the coming 4 months,
- −Known pregnancy or currently breastfeeding,
- −Men and women planning a pregnancy during the study or in the 12 weeks after stopping IPs
- −Hip or knee surgery planned in the coming 4 months,
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study does not fall into the standard research categories.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
What is being given or done in this study: CBD, THC, PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
There are 3 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 40 years to 80 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 100 people.
The study is currently expected to finish around February 2027.
The main measurement is taken over: Through study completion, an average of 1 year.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Feasibility outcome: pertaining to the enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → rate — measured over Through study completion, an average of 1 year.
Feasibility outcome: pertaining to the ProtocolProtocolThe detailed plan a study must follow.Read more → adherence — measured over Up to 8 weeks post-treatment.
Feasibility outcome: pertaining to data completeness — measured over Up to 8 weeks post-treatment.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06878417 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About CBDDrug
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.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About THCDrug
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.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
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.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 40 years to 80 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 40 years to 80 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Through study completion, an average of 1 year.
The study as a whole is currently expected to finish around 2027-02-28.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 100 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 2 locations, including: Toronto, Ontario, Canada; Montreal, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.