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CBD for Pain Following Orthopedic Shoulder Surgery
Cannabidiol (CBD) As A Pain Adjunct in Orthopedic Surgical Patients: A Randomized Control Trial
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * Above the age of 18 years old * Undergoing a rotator cuff repair surgery * Receiving standard anesthesia during surgery * If a subject is of reproductive potential, they must be on effective contraception one month prior, during treatment, and one month following treatment. Exclusion Criteria: * Under the age of 18 years old * History of revision shoulder arthroplasty * History of liver disease or impairment * Are currently taking valproate or clobazam * Are currently taking a moderate/strong CYP3A4 or CYP2C19 inhibitor * Are currently taking a strong CYP3A4 or CYP2C19 inducer * Are currently taking narcotics * History of substance/alcohol abuse * Those currently or previously under the care of a pain management specialist * History of marijuana/cannabidiol (not including topical) regular use within the past 6 months * Allergy related to cannabidiol * Allergy related to sesame seeds * Pregnancy (As part of standard of care, all female participants will be administered a urine pregnancy test prior to surgery. A negative test result is required to participate in the study.) * If you are taking any medications with known risks for suicidal behavior and ideation * If you have a diagnosed psychiatric disorder * If you are untreated for a diagnosed sleeping disorder * If you are actively breastfeeding * Patients currently taking central nervous system (CNS) depressants * Patients currently taking other drugs with known hepatotoxicity * Vulnerable populations. Patients taking concomitant medications which are substrate of uridine 5'-diphospho-glucuronosyltransferase 1-9 (UGT1A9), uridine diphosphate-glucuronosyltransferase 2B7 (UGT2B7), CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and P-gp will be monitored for potential adverse events based on the Epidiolex® label for the concomitant medication being used.
About the study
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
What is being tested
- Epidiolex (drug)
- Placebo oral solution (drug)
Sponsor: The Methodist Hospital Research Institute · Participants: 80 · Started: May 24, 2024
Contact the study team
- Haley M Goble, MPH, CRCC · Phone: 7134413930
- David N Armond, BS · Phone: 3462380206
Official record on ClinicalTrials.gov — NCT06381791
Locations in the U.S.
| Texas | Houston Methodist Hospital, Houston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.