Overview
The purpose of this study is to see if cannabidiol (CBD) orally dissolving tablets (ODTs) can lessen pain, improve function, and improve patient satisfaction in cases of knee osteoarthritis. CBD comes from the cannabis plant and is non-psychoactive (i.e. does not produce a 'high' or altered mental state) as compared to tetrahydrocannabinol (THC), another compound found in cannabis. Researchers are studying different forms of CBD for potential use in treating pain, inflammation, and illnesses.
Description
This will be a multi-center, double-blinded, randomized, placebo-controlled study. The study is comparing pain, outcomes, and patient satisfaction in two cohorts: patients with knee OA undergoing physiotherapy/home exercises who receive CBD and a placebo group with PT/home exercise program. Patients will be asked on treatment Day 1, 2, 7, and 14, 28, 42, and 84 to rate their pain according to the VAS scale. Additionally, patient satisfaction and clinical outcomes will be measured.
Eligibility
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