NCT06381791 · The Methodist Hospital Research Institute
CBD for Pain Following Orthopedic Shoulder Surgery
(CBD)
What this study 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 16, 2026 · Source of record for eligibility and locations