Using CBD to manage pain after shoulder surgery
Cannabidiol (CBD) As A Pain Adjunct in Orthopedic Surgical Patients: A Randomized Control Trial
This study is testing if a CBD medication can help people manage pain better after shoulder surgery compared to a placebo.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Methodist Hospital Research Institute Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06381791 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of Epidiolex (cannabidiol) as an additional pain management option for patients who have undergone orthopedic shoulder surgery. Participants will be randomly assigned to receive either Epidiolex or a placebo alongside their standard pain management regimen. They will track their pain levels and medication use in a diary for two weeks post-surgery, with follow-up calls from researchers to monitor compliance and safety. Bloodwork and surveys will be conducted to assess safety and pain outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults undergoing specific orthopedic shoulder surgeries such as total shoulder arthroplasty or rotator cuff repair.
Not a fit: Patients with a history of liver disease, substance abuse, or those currently using certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new pain management option for patients recovering from shoulder surgery.
How similar studies have performed: While the use of CBD for pain management is gaining interest, this specific approach in the context of orthopedic shoulder surgery is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Houston, Texas
- Houston Methodist Hospital — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Patrick McCulloch, MD — The Methodist Hospital Research Institute
- Study coordinator: Haley M Goble, MPH, CRCC
- Email: hmgoble@houstonmethodist.org
- Phone: 7134413930
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.