Cannabidiol dissolving tablets for knee osteoarthritis pain

Who can take part

• 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

Who cannot take part

• Patients that have been on opioid management for any reason just prior to the study
• 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
• Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.)
• 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
• 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
• 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)
• Renal failure (serum creatinine > 250 μmol/L [2.83 mg/dL]) or liver cirrhosis
• Younger than 40 years of age
• Older than 75 years of age
• Knee Injections within the last 3 months (cortisone, PRP, hyaluronic acid)
• Any patient considered a vulnerable subject: pregnant women or fetuses, children, cognitively impaired adults, prisoners
• Abnormal coagulation profile
• Patients with known inflammatory arthritis (such as rheumatoid arthritis, gout, pseudogout etc)
• Patients with a large effusion
• Patients with a BMI > 35
• Breastfeeding females
• Abnormal LFTs
• 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