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

NCT ID: NCT06588972

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-10-12

Brief 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.

Conditions

OSTEOARTHRITIS OF THE KNEE

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group 1

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

Group Type: PLACEBO_COMPARATOR

Medium Chain Triglyceride solution

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Group 2

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

Group Type: EXPERIMENTAL

Cannabis Sativa

Intervention Type: OTHER

Group 2: Cannabis sativa extract with CBD (45mg/day).

Interventions

Medium Chain Triglyceride solution

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Cannabis Sativa

Group 2: Cannabis sativa extract with CBD (45mg/day).

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Latin American Integration

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francisney P Nascimento, 1

Role: STUDY_DIRECTOR

Federal University of Latin American Integration

Locations

Federal University of Latin American Integration

Foz do Iguaçu, Paraná, Brazil

Countries

Brazil

Other Identifiers

CANOA

Identifier Type: -

Identifier Source: org_study_id