A Phase 1/2 interventional study of Epidiolex and Placebo oral solution in Shoulder Osteoarthritis and Rotator Cuff Injuries, sponsored by The Methodist Hospital Research Institute. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-16.
Sponsored by The Methodist Hospital Research Institute · Phase 1/2, Interventional, and Treatment
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:
Subjects will be randomized according to their surgery type. They will receive either the Epidiolex cannabidiol in addition to their standard of care pain regimen or a placebo in addition to their standard of care pain regimen. They will be asked to track a pain diary for 2 weeks postoperatively.
A member of the research team will conduct a follow-up telephone call on day 7 to assess subjects' drug compliance. Subjects will also be contacted for a safety monitoring call at day 7 and 1 week after completion of treatment in which they will disclose type, severity, onset, and duration of any adverse events. In addition, they will complete a suicidal assessment10 See attached safety screening document. After the 2 weeks, subjects will return the pain diary and vial of CBD/placebo at their postoperative appointment.
Subjects will also be asked to complete validated questionnaires via Houston Methodist's Redcap system once before surgery and again at 14 days postop. The surveys are with regards to sleep, activity, and pain and should take no more than 15 minutes to complete.
At their standard of care postoperative visit (11-17 days following surgery), another liver panel will be taken and their final safety monitoring screening will be conducted.
734 studies on the registry are indexed under Rotator Cuff Injuries; 161 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 538 interventional studies indexed under Rotator Cuff Injuries.
Browse Rotator Cuff Injuries studies →The Methodist Hospital Research Institute is the lead sponsor of 157 studies on the registry; 60 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 15 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Patients randomized to the Epidiolex group will take 150mg of Epidiolex with food twice daily for 14 days beginning the day of surgery.
Drug: Epidiolex
Patients randomized to the placebo group will take 150mg of oral placebo solution with food for 14 days beginning the day of surgery.
Drug: Placebo oral solution
150mg of Epidiolex
Also known as: Cannabidiol Oral Solution
150mg of Placebo oral solution
Also known as: Placebo
Primary - Pain Journal
Evaluation of postoperative pain journal responses from subjects. The pain diary will track their pain level on a Visual Analogue Scale (VAS) and their documented pain medication usage.
Time frame: 2 weeks
Survey Data
Evaluation of the survey data and questionnaires from baseline to the end of the two weeks post operative period.
Time frame: 2 weeks
Pain Disability Index (PDI)
This survey is designed to measure the degree to which aspects of a participant's life are disrupted by chronic pain. Each item on the survey is rated on an eleven point scale from no disability (0) to worst disability (10).
Time frame: 2 weeks
Pain, Enjoyment, General Activity (PEG) Scale
This survey tracks a participant's pain intensity and pain interference. Each item on the survey is rated on an eleven point scale from 0 to 10 with different measures at either end of the scale depending on which item (intensity or interference) is being evaluated.
Time frame: 2 weeks
Patient Health Questionnaire 4 (PHQ-4): The four-item patient health questionnaire for anxiety
This survey measures how frequently a patient was bothered by symptoms of anxiety or depression. It is measured on a four point scale from 0-3 with each number corresponding to how often a patient experienced a symptom with 0 being not at all, and 3 being nearly every day.
Time frame: 2 weeks
Pittsburgh Sleep Quality Index (PSQI)
This survey assesses the amount and quality of sleep that a patient has experienced in the last month. It is measured both with general free response questions and scaled questions reflecting frequency or lack thereof for a given issue (rated from Not during the past month to Three or more times a week).
Time frame: 2 weeks
Plan to share: No
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