Cannabidiol (CBD) in Pain Reduction for Knee Osteoarthritis

Eligibility 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
• * 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