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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Undergoing one of the following orthopedic shoulder surgeries:

‣ Total shoulder arthroplasty

⁃ Reverse total shoulder arthroplasty

⁃ Shoulder hemiarthroplasty

⁃ Rotator cuff repair

• 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.

Locations
United States
Texas
Houston Methodist Hospital
RECRUITING
Houston
Contact Information
Primary
Haley M Goble, MPH, CRCC
hmgoble@houstonmethodist.org
7134413930
Backup
David N Armond, BS
dnarmond@houstonmethodist.org
3462380206
Time Frame
Start Date: 2024-05-24
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 80
Treatments
Experimental: Epidiolex (cannabidiol)
Patients randomized to the Epidiolex group will take 150mg of Epidiolex with food twice daily for 14 days beginning the day of surgery.
Placebo_comparator: Placebo
Patients randomized to the placebo group will take 150mg of oral placebo solution with food for 14 days beginning the day of surgery.
Related Therapeutic Areas
Sponsors
Leads: The Methodist Hospital Research Institute

This content was sourced from clinicaltrials.gov

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