Actively Recruiting
CBD for Pain Following Orthopedic Shoulder Surgery
Led by The Methodist Hospital Research Institute · Updated on 2026-04-16
80
Participants Needed
1
Research Sites
187 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of the study is to learn if Epidiolex (cannabidiol) works as a additional pain medication in patients who have had orthopedic shoulder surgery. It is also to learn about safe dosages and identify any side effects after surgery. Researchers will compare Epidiolex to a placebo solution to see if Epidiolex lowers pain after shoulder surgery. Participants will: * track their pain and what medications they use every day in a provided pain diary. A researchers will call every seven days to check on the participant and diary. * Complete two short surveys. Once before surgery and once after. * Have bloodwork tested after surgery
CONDITIONS
Official Title
CBD for Pain Following Orthopedic Shoulder Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Above the age of 18 years old
- Undergoing a rotator cuff repair surgery
- Receiving standard anesthesia during surgery
- If of reproductive potential, using effective contraception one month before, during, and one month after treatment
You will not qualify if you...
- Under the age of 18 years old
- History of revision shoulder arthroplasty
- History of liver disease or impairment
- Currently taking valproate or clobazam
- Currently taking moderate or strong CYP3A4 or CYP2C19 inhibitors
- Currently taking strong CYP3A4 or CYP2C19 inducers
- Currently taking narcotics
- History of substance or alcohol abuse
- Currently or previously under care of a pain management specialist
- History of regular marijuana or cannabidiol use (not topical) within the past 6 months
- Allergy to cannabidiol
- Allergy to sesame seeds
- Pregnant (negative pregnancy test required before surgery)
- Taking medications with known risks for suicidal behavior or ideation
- Diagnosed psychiatric disorder
- Untreated diagnosed sleeping disorder
- Actively breastfeeding
- Currently taking central nervous system depressants
- Taking other drugs with known liver toxicity
- Vulnerable populations
- Taking medications metabolized by UGT1A9, UGT2B7, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or P-gp will be monitored for possible side effects
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
H
Haley M Goble, MPH, CRCC
CONTACT
D
David N Armond, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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