Analgesic Effects of a Treatment With Cannabis Sativa Extract in Patients With Knee Osteoarthriti… (NCT06588972) | Clinical Trial Compass
CompletedPhase 2
Analgesic Effects of a Treatment With Cannabis Sativa Extract in Patients With Knee Osteoarthritis - CANOA (Cannabis for Osteoarthritis)
Brazil45 participantsStarted 2024-01-01
Plain-language summary
Osteoarthritis (OA) is the most prevalent joint disease in humans, often causing disability in affected individuals, especially the elderly. OA is characterized by mechanical joint pain, crepitus and short-term post-immobilization stiffness. OA pain has a variable pathophysiology and, despite the many pharmacological options available, its treatment is often ineffective and has significant side effects. The search for more effective and safer treatments is therefore essential in the field of OA. Among the possible treatments are substances derived from cannabis. Cannabis plants have been used for various purposes by humankind for thousands of years. Its best-known species, Cannabis sativa, has more than a hundred substances called cannabinoids or, more specifically, phytocannabinoids, the most important of which is cannabidiol (CBD). Although many pre-clinical studies indicate the usefulness of phytocannabinoids, clinical evidence for their application is currently scarce. Therefore, this project aims to investigate the effects of a CBD-rich extract of Cannabis sativa on the pain of patients with knee OA, as well as the possible adverse events of this treatment.
Who can participate
Age range
30 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Have a diagnosis of knee osteoarthritis, according to the ACR classification criteria (ALTMAN, 1986);
* Have a moderate or high level of pain induced by osteoarthritis (visual analog scale scale equal to or greater than 5);
* Voluntarily agree to take part in the study by signing the Informed Consent Form (ICF);
* For women of reproductive age, a negative Beta-HCG test, and use of a contraceptive method throughout the study.
* For women of reproductive age, a negative Beta-HCG test, and use of a contraceptive method throughout the study and 3 months after its conclusion.
* Age range of thirty (30) to seventy (70) years.
Exclusion Criteria:
* People with heart failure, hypertension or any heart disease;
* People with chronic kidney disease or liver failure;
* Patients with chronic inflammatory diseases;
* Patients with severe psychiatric illnesses, such as severe mood disorders and psychotic disorders;
* Current use of cannabinoids by any route of administration.
* Pregnant women
* Lactating women
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain levels
Timeframe: 2 months
Trial details
NCT IDNCT06588972
SponsorFederal University of Latin American Integration