OSTEOARTHRITIS OF THE KNEEPhase 2NCT06588972
Analgesic Effects of a Treatment With Cannabis Sativa Extract in Patients With Knee Osteoarthritis - CANOA (Cannabis for Osteoarthritis)
A Phase 2 study testing Medium Chain Triglyceride solution and Cannabis Sativa in people with OSTEOARTHRITIS OF THE KNEE, run by Federal University of Latin American Integration at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- OSTEOARTHRITIS OF THE KNEE
- What is being tested?
- Medium Chain Triglyceride solution and Cannabis Sativa
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2024to 12 Oct 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Latin American Integration
Foz do Iguaçu, Paraná, 85870-650
About this study
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
- Being tested
- Medium Chain Triglyceride solution, Cannabis Sativa
- Keywords
- Osteoarthritis, Pain, Cannabinoids, Cannabinoid safety, Tetrahydrocannabinol, Cannabidiol
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medium Chain Triglyceride solutionDietary supplement
Placebo
Cannabis SativaOther
Group 2: Cannabis sativa extract with CBD (45mg/day).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Placebo comparator | placebo (solution of Medium Chain Triglycerides, without any active ingredient) Receives: Dietary Supplement: Medium Chain Triglyceride solution |
| Group 2 | Experimental | Cannabis sativa extract with a CBD (45 mg/day) Receives: Other: Cannabis Sativa |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Secondary outcomes (8)
Short Form Health Survey (SF-12)
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.
Measured: 2 months
Depression
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.
Measured: 2 months
Adverse events
presence of adverse events (AE) - proportion of patients with AE in the placebo and intervention groups;
Measured: 2 months
Serious adverse events
presence of serious adverse events (AEs) - description of the serious AEs that may appear in each group.
Measured: 2 months
Change in sleep quality
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
Measured: 2 months
Renal Function Panel
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.
Measured: 2 months
Visual Analogue Scale (VAS)
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
Measured: 2 month
Hepatic Panel
Used to monitor liver function in patients, as pacientes are receiving an oil-based medication that may overload the liver.
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jan 2024
- Primary completion10 Oct 2024
- Study completion12 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OSTEOARTHRITIS OF THE KNEEStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Latin American Integration
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francisney P Nascimento, 1, Study director, Federal University of Latin American Integration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588972
- Sponsor's protocol ID
- CANOA
- Status last verified
- Jun 2025
- First submitted
- 12 Apr 2024
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41487518
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effects of a Treatment With Cannabis Sativa Extract in Patients With Knee Osteoarthritis - CANOA (Cannabis for Osteoarthritis)
- ClinicalTrials.gov ID
- NCT06588972
- Acronym / sponsor ID
- CANOA
- Conditions
- OSTEOARTHRITIS OF THE KNEE
- Keywords
- Osteoarthritis, Pain, Cannabinoids, Cannabinoid safety, Tetrahydrocannabinol, Cannabidiol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Federal University of Latin American IntegrationUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 12 Oct 2024 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Placebo comparator | Dietary Supplement: Medium Chain Triglyceride solutionplacebo (solution of Medium Chain Triglycerides, without any active ingredient) |
| Group 2 | Experimental | Other: Cannabis SativaCannabis sativa extract with a CBD (45 mg/day) |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medium Chain Triglyceride solutionPlacebo | Dietary supplement | Group 1 |
| Cannabis SativaGroup 2: Cannabis sativa extract with CBD (45mg/day). | Other | Group 2 |
Primary outcome
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.
8 secondary outcomes
Short Form Health Survey (SF-12)
Time frame: 2 months
Depression
Time frame: 2 months
Adverse events
Time frame: 2 months
Serious adverse events
Time frame: 2 months
Change in sleep quality
Time frame: 2 months
Renal Function Panel
Time frame: 2 months
Visual Analogue Scale (VAS)
Time frame: 2 month
Hepatic Panel
Time frame: 2 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Derived from this study: PubMed 41487518Mojoli 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisney P Nascimento, 1 study director
Federal University of Latin American Integration
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Medium Chain Triglyceride solution and Cannabis Sativa in people with OSTEOARTHRITIS OF THE KNEE, run by Federal University of Latin American Integration at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain levels (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06588972, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.