Cannabidiol (CBD) in Pain Reduction for Knee Osteoarthritis

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 thatperiod

• VAS ≥ 4

• Patients ages 40-75, inclusive

• If female patients are pre-menopausal they must be currently practicing effectiveforms of two types of birth control, which are defined as those, alone or incombination, that result in a low failure rate (less than 1% per year) when usedconsistently 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 abnormalcoagulation 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 clinicallysignificant by the treating physicians

• Patients taking strong CYP3A4 and CYP2C19 inducers (listed below) concomitantly willbe considered for exclusion if determined to be clinically significant by thetreating physicians

• Patients taking substrates of UTG1A9, UTGB17, CYP2A1, CYP2B6, CYP2C8, CYP2C9 andCYP2C19 (listed below) concomitantly will be considered for exclusion if determinedto be clinically significant by the treating physicians