CBD for Knee Osteoarthritis
Sub-Lingual Administration of Cannabidiol for Knee Osteoarthritis
University of Florida
30 participants
Jun 14, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria2
- established clinical diagnosis of knee osteoarthritis (KOA)
- moderate to severe knee pain (≥4/10) with physical activity in one or both knees
Exclusion Criteria12
- pregnant (urine pregnancy test) or lactating
- current cannabis (THC and/or CBD) use (urine drug screen)
- any prior or ongoing medical condition that, in the investigators' opinion, could adversely affect the safety of the subject
- 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
- any exposure to another investigational drug within 3 months prior to screening
- BMI ≥ 45
- current use of any enzyme-modifying drugs, including strong inhibitors or strong inducers of cytochrome P (CYP) enzymes
- history of:
- suicidal ideation or self-harm behavior
- seizure disorder or traumatic brain injury,
- liver or kidney disease, and
- cardiovascular diseases
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Interventions
Administered thrice daily (with food) using a sublingual route of administration
Administered thrice daily (with food) using a sublingual route of administration
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06414473