NCT06234631

Cannabidiol for Postoperative Opioid Reduction in Primary Total Knee Arthroplasty

Cannabidiol for Postoperative Opioid Reduction in Primary Total Knee Arthroplasty - a Randomized, Two by Two Factorial, Double-blind, Placebo-controlled Clinical Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 380 (estimated)
• Sponsor: Chad Brummett · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Knee Replacement Surgery
• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	Epidiolex 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.
OTHER	Placebo	Participants will be instructed to take one hour before or two hours after eating a meal.

Timeline

• Start date: 2024-03-13
• Primary completion: 2029-01-01
• Completion: 2029-01-01
• First posted: 2024-01-31
• Last updated: 2026-04-15

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study