Actively Recruiting
Cannabidiol (CBD) As A Pain Adjunct in Orthopedic Surgical Patients: A Randomized Control Trial
Led by The Methodist Hospital Research Institute · Updated on 2026-04-16
80
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether Epidiolex (cannabidiol) can help reduce pain when added to standard pain medications after orthopedic shoulder surgery, specifically rotator cuff repair. This randomized, triple-blind study aims to identify safe dosage levels and any side effects occurring after surgery. The trial compares Epidiolex to a placebo solution to see if it lowers postoperative pain effectively. Participants will be randomly assigned based on their surgery type to receive either 150mg of Epidiolex or a 150mg placebo oral solution twice daily with food for 14 days starting on the day of surgery. During this period, participants will track their pain and medication use daily in a provided pain diary. Researchers will call participants weekly to check on their diary and medication compliance and monitor any adverse events. Participants will complete two short surveys before and two weeks after surgery about sleep, activity, and pain. Blood tests, including liver panels, will be done after surgery and at the postoperative visit 11 to 17 days later. Safety monitoring calls will assess any side effects or concerns. The study's primary outcome is pain recorded in the pain journal over two weeks, with additional assessments of pain disability, general activity, anxiety, and sleep quality.
CONDITIONS
Brief 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 prior, 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/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
- Regular use of marijuana or cannabidiol (not topical) in past 6 months
- Allergy to cannabidiol or sesame seeds
- Pregnancy
- Taking medications with known suicidal risk
- Diagnosed psychiatric disorder
- Untreated sleeping disorder
- Actively breastfeeding
- Currently taking CNS depressants
- Taking other drugs with known liver toxicity
- Vulnerable populations
- Use of medications affecting UGT1A9, UGT2B7, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or P-gp enzymes will be monitored for safety concerns based on Epidiolex labeling
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) before surgery for eligibility assessment and baseline questionnaires
Duration - 14 days
Participants take either Epidiolex or placebo twice daily with food for 14 days starting the day of surgery, and track their pain using a diary.
Daily self-administration and pain diary tracking for 14 days
Duration - Up to 3 weeks following surgery
Participants complete safety monitoring calls on day 7 and 1 week after treatment ends, complete follow-up questionnaires, and return pain diary and medication at their postoperative appointment.
1 telephone call on day 7, 1 telephone call 1 week after treatment, and 1 in-person postoperative visit between days 11-17
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
D
David N Armond, BS
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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