NCT06381791

CBD for Pain Following Orthopedic Shoulder Surgery

Cannabidiol (CBD) As A Pain Adjunct in Orthopedic Surgical Patients: A Randomized Control Trial

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: The Methodist Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

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.

Conditions

• Shoulder Osteoarthritis
• Rotator Cuff Injuries

Interventions

Type	Name	Description
DRUG	Epidiolex	150mg of Epidiolex
DRUG	Placebo oral solution	150mg of Placebo oral solution

Timeline

• Start date: 2024-05-24
• Primary completion: 2026-12-30
• Completion: 2027-12-30
• First posted: 2024-04-24
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study