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Epidiolex as a Pain Adjunct in Orthopedic Shoulder Surgery
NCT06381791Phase 2
Key facts
- Status
- Recruiting
- Start
- May 2024
- Primary completion
- Dec 2026
- Countries
- 1
- Sponsor
- Houston Methodist Research Institute
- Modality
- Small Molecules
- Drugs
- cannabidiol
- Conditions
- rotator cuff injuryshoulder osteoarthritis
01
Overview
Phase 2, randomised trial in rotator cuff injury and shoulder osteoarthritis comparing Epidiolex (cannabidiol) with Placebo (2 arms). Primary endpoint: Pain Journal at 2 weeks. Started May 2024; status: recruiting.
02
Design
2 arms- Study design
- Randomized
Epidiolex (cannabidiol)
150mg of Epidiolex with food twice daily for 14 days beginning the day of surgery.
Placebo
150mg of oral placebo solution with food for 14 days beginning the day of surgery.
03
Who it enrols
Adults undergoing rotator cuff repair surgery, excluding those with liver disease, psychiatric disorders, substance abuse history, or taking interacting medications (e.g., CYP inhibitors/inducers, valproate, clobazam, narcotics).
04
Endpoints
Primary
Pain Journal
Secondary
Survey Data
Pain Disability Index
Pain, Enjoyment, General Activity Scale
Patient Health Questionnaire 4
Pittsburgh Sleep Quality Index
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