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Completed

NCT Number: NCT06588972

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

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.

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Key information

Conditions

Osteoarthritis of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Federal University of Latin American Integration

Foz do Iguaçu, Paraná, 85870-650, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medium Chain Triglyceride solution

Dietary Supplement

Placebo

Cannabis Sativa

Other

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

Primary outcomes

  1. Pain levels

    Time frame: 2 months

    Change in pain levels, according to the score in the "pain" domain of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), using the Likert scale to assign a value to the answers obtained from the participants. The pain levels according to the score are 0-8 mild, greater than 8-14 moderate, greater than 14- 20 high.

Secondary outcomes

  1. Short Form Health Survey (SF-12)

    Time frame: 2 months

    Change in the Short Form Health Survey (SF-12) quality of life scores, according to the "maximal walking" and "activities of daily living" domains, where a score of 0 is the worst quality of life and 100 the best.

  2. Depression

    Time frame: 2 months

    Changes in levels of depression using the Beck Depression scale. Changes in depression levels using the Beck depression scale. The disease level values range from 0-9 indicating that the individual is not depressed, 10-18 indicating mild to moderate depression, 19-29 indicating moderate to severe depression and 30-63 indicating severe depression.

  3. Adverse events

    Time frame: 2 months

    presence of adverse events (AE) - proportion of patients with AE in the placebo and intervention groups;

  4. Serious adverse events

    Time frame: 2 months

    presence of serious adverse events (AEs) - description of the serious AEs that may appear in each group.

  5. Change in sleep quality

    Time frame: 2 months

    The Pittsburgh scale was used to see if there was any change in the participants' quality of sleep. The scale used classifies sleep quality as follows:

    • Good 0-4
    • Bad -10
    • Presence of sleep disturbance greater than 10

  6. Renal Function Panel

    Time frame: 2 months

    Used as form to identify any renal impairment in pacientes that could result in any need of adjusting the dose or need to leave the study.

  7. Visual Analogue Scale (VAS)

    Time frame: 2 month

    It is used in the healthcare field to measure the intensity of pain a person feels, usually on a scale from 0 to 10, where 0 means 'no pain' and 10 means 'the worst pain imaginable

  8. Hepatic Panel

    Time frame: 2 month

    Used to monitor liver function in patients, as pacientes are receiving an oil-based medication that may overload the liver.

Sponsors and collaborators

Lead sponsor

Federal University of Latin American Integration

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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