RECRUITING

CBD for Pain Following Orthopedic Shoulder Surgery

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-05-24
Study Completion:2027-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06381791

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Undergoing one of the following orthopedic shoulder surgeries:
  2. * Total shoulder arthroplasty
  3. * Reverse total shoulder arthroplasty
  4. * Shoulder hemiarthroplasty
  5. * Rotator cuff repair
  6. * Receiving standard anesthesia during surgery
  7. * If a subject is of reproductive potential, they must be on effective contraception one month prior, during treatment, and one month following treatment.
  1. * Not above the age of 18 years old
  2. * History of revision shoulder arthroplasty
  3. * History of liver disease or impairment
  4. * Are currently taking valproate or clobazam
  5. * Are currently taking a moderate/strong CYP3A4 or CYP2C19 inhibitor
  6. * Are currently taking a strong CYP3A4 or CYP2C19 inducer
  7. * Are currently taking narcotics
  8. * History of substance/alcohol abuse
  9. * Those currently or previously under the care of a pain management specialist
  10. * History of marijuana/cannabidiol (not including topical) regular use within the past 6 months
  11. * Allergy related to cannabidiol
  12. * Allergy related to sesame seeds
  13. * Pregnancy (As part of standard of care, all female participants will be administered a urine pregnancy test prior to surgery. A negative test result is required to participate in the study.)
  14. * If you are taking any medications with known risks for suicidal behavior and ideation
  15. * If you have a diagnosed psychiatric or sleeping disorder
  16. * If you are actively breastfeeding
  17. * Patients currently taking central nervous system (CNS) depressants
  18. * Patients currently taking other drugs with known hepatotoxicity
  19. * Vulnerable populations.

Contacts and Locations

Study Contact

Haley M Goble, MPH, CRCC
CONTACT
7134413930
hmgoble@houstonmethodist.org
David N Armond, BS
CONTACT
3462380206
dnarmond@houstonmethodist.org

Principal Investigator

Patrick McCulloch, MD
PRINCIPAL_INVESTIGATOR
The Methodist Hospital Research Institute

Study Locations (Sites)

Houston Methodist Hospital
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: The Methodist Hospital Research Institute

  • Patrick McCulloch, MD, PRINCIPAL_INVESTIGATOR, The Methodist Hospital Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-24
Study Completion Date2027-12-30

Study Record Updates

Study Start Date2024-05-24
Study Completion Date2027-12-30

Terms related to this study

Keywords Provided by Researchers

  • CBD
  • Cannabidiol
  • Epidiolex

Additional Relevant MeSH Terms

  • Shoulder Osteoarthritis
  • Rotator Cuff Injuries