CBD for Pain Following Orthopedic Shoulder Surgery
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
Conditions:
๐Ÿฆ  Shoulder Osteoarthritis ๐Ÿฆ  Rotator Cuff Injuries
๐Ÿ—“๏ธ Study Start (Actual) 24 May 2024
๐Ÿ—“๏ธ Primary Completion (Estimated) 30 December 2026
โœ… Study Completion (Estimated) 30 December 2027
๐Ÿ‘ฅ Enrollment (Estimated) 80
๐Ÿ”ฌ Study Type INTERVENTIONAL
๐Ÿ“Š Phase PHASE1
Locations:
๐Ÿ“ Houston, Texas, United States

๐Ÿ“‹ Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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.

    Exclusion Criteria:

    • * Not between the ages of 18-55 years old
    • * History of revision shoulder arthroplasty
    • * History of liver disease or impairment
    • * Are currently taking valproate or clobazam
    • * Are currently taking a moderate/strong CYP3A4 or CYP2C19 inhibitor
    • * Are currently taking a strong CYP3A4 or CYP2C19 inducer
    • * Are currently taking narcotics
    • * History of substance/alcohol abuse
    • * Those currently or previously under the care of a pain management specialist
    • * History of marijuana/cannabidiol (not including topical) regular use within the past 6 months
    • * Allergy related to cannabidiol
    • * Allergy related to sesame seeds
    • * 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.)
    • * If you are taking any medications with known risks for suicidal behavior and ideation
    • * If you have a diagnosed psychiatric or sleeping disorder
    • * If you are actively breastfeeding
    • * Patients currently taking central nervous system (CNS) depressants
    • * Patients currently taking other drugs with known hepatotoxicity
    • * Vulnerable populations.
    • 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 Epidiolexยฎ label for the concomitant medication being used.
Ages Eligible for Study: 18 Years to 55 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

๐Ÿ—“๏ธ 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

  • First Submitted 11 April 2024
  • First Submitted that Met QC Criteria 19 April 2024
  • First Posted 24 April 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 28 May 2024
  • Last Update Posted 29 May 2024
  • Last Verified May 2024