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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epidiolex (cannabidiol) | Experimental | Patients randomized to the Epidiolex group will take 150mg of Epidiolex with food twice daily for 14 days beginning the day of surgery. |
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| Placebo | Placebo Comparator | Patients randomized to the placebo group will take 150mg of oral placebo solution with food for 14 days beginning the day of surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidiolex | Drug | 150mg of Epidiolex |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Survey Data | Evaluation of the survey data and questionnaires from baseline to the end of the two weeks post operative period. | 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). |
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Inclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haley M Goble, MPH, CRCC | Contact | 7134413930 | hmgoble@houstonmethodist.org | |
| David N Armond, BS | Contact | 3462380206 | dnarmond@houstonmethodist.org |
| Name | Affiliation | Role |
|---|---|---|
| Patrick McCulloch, MD | The Methodist Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Methodist Hospital | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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This study is designed as a randomized, double-blinded controlled trial. Patients will be recruited in clinic preoperatively prior to their scheduled procedure. Patients and the treating physician/research study team will be blinded to the treatment arm. Patients will be randomized to either the test group, which will be prescribed Epidiolex (cannabidiol) postoperatively in addition to the standard pain regimen, or the control group, which will have a placebo provided in addition to the standard pain regimen.
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| Placebo oral solution | Drug | 150mg of Placebo oral solution |
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| 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. | 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. | 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). | 2 weeks |