Cannabidiol for Postoperative Opioid Reduction in Primary Total Knee Arthroplasty - a Randomized, Two by Two Factorial, Double-blind, Placebo-controlled Clinical Trial
Chad Brummett
Summary
The goal of this study is to better understand how daily treatment with cannabidiol (CBD) affects the need for opioid pain medication, as well as pain, inflammation and other related symptoms, after knee replacement surgery. The information collected in this study is necessary to help understand whether CBD may be a useful medication before and/or after surgery. The study hypothesis is that CBD exerts opioid-sparing effects through anti-inflammatory, analgesic, and anxiolytic mechanisms.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Willing and able to read, understand, and sign the informed consent (English) * Willingness to participate in all study measures and restrictions, including patient-reported outcomes and longitudinal follow-up * Scheduled for surgery: primary total knee arthroplasty * Primary diagnosis of osteoarthritis of the surgical knee * Individuals of reproductive potential must agree to use acceptable birth control (defined in manual of operating procedures). This includes currently practicing an effective form of two types of birth control for women of childbearing potential, whi…
Interventions
- DrugEpidiolex oral solution
Participants assigned to CBD will take the medication one hour before or two hours after eating a meal. If participants can't tolerate the full-strength dose, the participant can decrease the dosing to 0.75 milliliter twice a day. If this is still not well tolerated, dosing can further be decreased to 0.75 milliliter once per day in the evening.
- OtherPlacebo
Participants will be instructed to take one hour before or two hours after eating a meal.
Locations (2)
- University of MichiganAnn Arbor, Michigan
- Henry Ford Health SystemDetroit, Michigan