Trial Parameters
Brief Summary
Osteoarthritis is a disease that affects millions of Americans and is the leading cause of persistent pain and physical disability in the older adult population. Many physically active Americans have reported pain-relieving effects of cannabidiol (CBD) that can reduce or eliminate use of nonsteroidal anti-inflammatory drugs (NSAIDs) for activity-related pain with minimal to no side effects. Long-term use of over-the-counter medications, including NSAIDs, can pose a significant health risk, and therefore clinical research on the safety and efficacy of CBD is needed.
Eligibility Criteria
Inclusion Criteria: 1. established clinical diagnosis of knee osteoarthritis (KOA) 2. moderate to severe knee pain (≥4/10) with physical activity in one or both knees Exclusion Criteria: 1. pregnant (urine pregnancy test) or lactating 2. current cannabis (THC and/or CBD) use (urine drug screen) 3. any prior or ongoing medical condition that, in the investigators' opinion, could adversely affect the safety of the subject 4. any major surgery within 3 months prior to recruitment or planned orthopedic surgery for any time during this study which would interfere with the ability to report pain or quality of life outcome measures 5. any exposure to another investigational drug within 3 months prior to screening 6. BMI ≥ 45 7. current use of any enzyme-modifying drugs, including strong inhibitors or strong inducers of cytochrome P (CYP) enzymes 8. history of: 1. suicidal ideation or self-harm behavior 2. seizure disorder or traumatic brain injury, 3. liver or kidney disease, and 4. cardiovas