NCT06381791 CBD for Pain Following Orthopedic Shoulder Surgery
| NCT ID | NCT06381791 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | The Methodist Hospital Research Institute |
| Condition | Shoulder Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-05-24 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 80 participants in total. It began in 2024-05-24 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Patrick McCulloch, MD
PRINCIPAL INVESTIGATOR
The Methodist Hospital Research Institute
Frequently Asked Questions
Who can join the NCT06381791 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Shoulder Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06381791 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06381791 currently recruiting?
Yes, NCT06381791 is actively recruiting participants. Contact the research team at hmgoble@houstonmethodist.org for enrollment information.
Where is the NCT06381791 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT06381791 clinical trial?
NCT06381791 is sponsored by The Methodist Hospital Research Institute. The principal investigator is Patrick McCulloch, MD at The Methodist Hospital Research Institute. The trial plans to enroll 80 participants.