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

NCT06588972 | Completed Phase 2 DMC

• 1 other identifier: CANOA
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Keywords

Osteoarthritis; Pain; Cannabinoids; Cannabinoid safety; Tetrahydrocannabinol; Cannabidiol

Outcome Measures

Primary Outcomes (1)

• Pain levels

  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.

  2 months

Secondary Outcomes (8)

• Short Form Health Survey (SF-12)

  2 months

• Depression

  2 months

• Adverse events

  2 months

• Serious adverse events

  2 months

• Change in sleep quality

  2 months

Study Arms (2)

Group 1

PLACEBO COMPARATOR

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

Dietary Supplement: Medium Chain Triglyceride solution

Group 2

EXPERIMENTAL

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

Other: Cannabis Sativa

Interventions

Medium Chain Triglyceride solution DIETARY_SUPPLEMENT

Placebo

Group 1

Cannabis Sativa OTHER

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

Group 2

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Latin American Integration: lead

Study Sites (1)

Federal University of Latin American Integration

Foz do Iguaçu, Paraná, 85870-650, Brazil

Location

Related Publications (1)

• Mojoli A, Haider O, Fakih Y, Luz Goncalves MV, Zepeda Rojas B, Xaia G, Krefta E, Bicca MA, Lopes de Mari T, Ferreira CF, Cezar-Dos-Santos F, Toci AT, Nascimento FP. Effects and safety of a CBD-rich Cannabis sativa oil in knee osteoarthritis: a double-blind, randomized, placebo-controlled trial - CANOA - cannabis for osteoarthritis. Front Pharmacol. 2025 Dec 19;16:1657065. doi: 10.3389/fphar.2025.1657065. eCollection 2025.

  PMID: 41487518 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Pain

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Francisney P Nascimento, 1

  Federal University of Latin American Integration

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: September 19, 2024
• Study Start: January 1, 2024
• Primary Completion: October 10, 2024
• Study Completion: October 12, 2024
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)