CBD for Pain Following Orthopedic Shoulder Surgery

Status Recruiting

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06381791
Study type	Interventional
Source	The Methodist Hospital Research Institute
Contact	Haley M Goble, MPH, CRCC
Phone	7134413930
Email	hmgoble@houstonmethodist.org
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	May 24, 2024
Completion date	December 30, 2027

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

CBD for Pain Following Orthopedic Shoulder Surgery — CBD

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms