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Tests treatment safety and results for Osteoarthritis of Knee
Official title Cannabinoids for Osteoarthritis Pain Effectiveness Trial
ClinicalTrials.gov ID: NCT06878417
What this study is testing
What is CBD?
CBD is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for osteoarthritis of knee.
Also referred to as AVCN319301a.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- 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
- Able to self-report, understand and read English or French
You likely can't join if
- 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.),
- Contraindications to taking cannabis/cannabinoids,
- Used nabilone or nabiximols in the last 30 days,
See the full eligibility criteria
- 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
- Able to self-report, understand and read English or French
- 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.),
- 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 washout),
- 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,
- Known pregnancy or currently breastfeeding,
- Men and women planning a pregnancy during the study or in the 12 weeks after stopping IPs
- No fixed address or a plan to change addresses in the coming 4 months,
- Known or suspected allergy to palm/coconut oil
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada; Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.