Analgesic Effects of a Treatment With Cannabis Sativa Extract in Patients With Knee Osteoarthritis - CANOA (Cannabis for Osteoarthritis)

Federal University of Latin American Integration

Status and phase: Completed; Phase 2

Conditions: OSTEOARTHRITIS OF THE KNEE

Treatments: Dietary Supplement: Medium Chain Triglyceride solution; Other: Cannabis Sativa

Study type: Interventional

Funder types: Other

Identifiers

NCT06588972

CANOA

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 2 patient groups, including a placebo group

Group 1

Placebo Comparator group

Description:

placebo (solution of Medium Chain Triglycerides, without any active ingredient)

Treatment:

Dietary Supplement: Medium Chain Triglyceride solution

Group 2

Experimental group

Description:

Cannabis sativa extract with a CBD (45 mg/day)

Treatment:

Other: Cannabis Sativa