Using CBD to reduce pain in knee osteoarthritis
The Use of Cannabidiol (CBD) in Pain Reduction for Knee Osteoarthritis. A Double-Blind, Randomized Control Study
This study is testing if taking CBD tablets can help people with knee osteoarthritis feel less pain and move better while they do physiotherapy and exercises at home.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05020028 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of orally dissolving cannabidiol (CBD) tablets in reducing pain and improving function in patients with knee osteoarthritis. It is a multi-center, double-blinded, randomized, placebo-controlled trial comparing outcomes between patients receiving CBD and those receiving a placebo while undergoing physiotherapy and home exercises. Participants will rate their pain and satisfaction at multiple time points throughout the treatment period to assess the impact of CBD on their condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40-75 with knee osteoarthritis experiencing significant pain for at least three months.
Not a fit: Patients with recent knee injections, cognitive impairments, or a history of cannabis abuse may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-psychoactive treatment option for pain relief in knee osteoarthritis patients.
How similar studies have performed: Other studies have shown promise in using CBD for pain management, but this specific approach is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients presenting with knee osteoarthritis (KL Grade II-III) * Knee pain for at least three months, occurring in at least half of the days in that period * VAS ≥ 4 * Patients ages 40-75, inclusive * If female patients are pre-menopausal they must be currently practicing effective forms of two types of birth control, which are defined as those, alone or in combination, that result in a low failure rate (less than 1% per year) when used consistently and correctly * Male patients must be using an effective form of contraception Exclusion Criteria: * Knee Injections within the last 3 months (cortisone, PRP, hyaluronic acid) * Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.) * Younger than 40 years of age * Older than 75 years of age * Any patient considered a vulnerable subject: pregnant women or fetuses, children, cognitively impaired adults, prisoners * History of cannabis abuse or dependence * History of coagulation abnormalities and thromboembolic disease or current abnormal coagulation test values * History of stroke or acute coronary syndromes within 3 months * Abnormal coagulation profile * Renal failure (serum creatinine \> 250 μmol/L \[2.83 mg/dL\]) or liver cirrhosis * Patients that have been on opioid management for any reason just prior to the study * Patients with known inflammatory arthritis (such as rheumatoid arthritis, gout, pseudogout etc) * Patients with a large effusion * Patients with a BMI \> 35 * Patients meeting the DSM-V for major psychiatric illness, such as bipolar disorder * Patients diagnosed with major depression, psychosis, or substance abuse disorder * Patients with current or a history of suicidal ideation * Breastfeeding females * Abnormal LFTs * Patients with major neurological disorders, such as dementia, Parkinson's disease, cognitive impairment, epilepsy, history of traumatic brain/head injury, or seizures * Patients with moderate (Child-Pugh B) and severe hepatic impairment (Child-Pugh C). * Patients taking moderate or strong inhibitors of CYP3A4 and CYP2C19 (listed below) concomitantly will be considered for exclusion if determined to be clinically significant by the treating physicians * Patients taking strong CYP3A4 and CYP2C19 inducers (listed below) concomitantly will be considered for exclusion if determined to be clinically significant by the treating physicians * Patients taking substrates of UTG1A9, UTGB17, CYP2A1, CYP2B6, CYP2C8, CYP2C9 and CYP2C19 (listed below) concomitantly will be considered for exclusion if determined to be clinically significant by the treating physicians
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Michael J Alaia, MD — NYU Langone Health
- Study coordinator: Michael J Alaia, MD
- Email: michael.alaia@nyulangone.org
- Phone: 646-501-7223
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.