CBD for Pain Following Orthopedic Shoulder Surgery (CBD)

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

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

Study Overview

• Status: Recruiting
• Conditions: Rotator Cuff Injuries; Shoulder Osteoarthritis
• Intervention / Treatment: Drug: Epidiolex; Drug: Placebo oral solution

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Haley M Goble, MPH, CRCC; Phone Number: 7134413930; Email: hmgoble@houstonmethodist.org
• Study Contact Backup: Name: David N Armond, BS; Phone Number: 3462380206; Email: dnarmond@houstonmethodist.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Houston Methodist Hospital
      • Principal Investigator: Patrick C McCulloch, MD
      • Contact: Haley M Goble, MHA, CRCC; Phone Number: 7134413930; Email: hmgoble@houstonmethodist.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Above the age of 18 years old
• Undergoing a rotator cuff repair surgery
• 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:

• Under the age of 18 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 disorder
• If you are untreated for a diagnosed 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 Epidiolex® label for the concomitant medication being used.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Epidiolex; 150mg of Epidiolex; Other Names: Cannabidiol Oral Solution
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.	Drug: Placebo oral solution; 150mg of Placebo oral solution; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary - Pain Journal	Evaluation of postoperative pain journal responses from subjects. The pain diary will track their pain level on a Visual Analogue Scale (VAS) and their documented pain medication usage.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survey Data	Evaluation of the survey data and questionnaires from baseline to the end of the two weeks post operative period.	2 weeks
Pain Disability Index (PDI)	This survey is designed to measure the degree to which aspects of a participant's life are disrupted by chronic pain. Each item on the survey is rated on an eleven point scale from no disability (0) to worst disability (10).	2 weeks
Pain, Enjoyment, General Activity (PEG) Scale	This survey tracks a participant's pain intensity and pain interference. Each item on the survey is rated on an eleven point scale from 0 to 10 with different measures at either end of the scale depending on which item (intensity or interference) is being evaluated.	2 weeks
Patient Health Questionnaire 4 (PHQ-4): The four-item patient health questionnaire for anxiety	This survey measures how frequently a patient was bothered by symptoms of anxiety or depression. It is measured on a four point scale from 0-3 with each number corresponding to how often a patient experienced a symptom with 0 being not at all, and 3 being nearly every day.	2 weeks
Pittsburgh Sleep Quality Index (PSQI)	This survey assesses the amount and quality of sleep that a patient has experienced in the last month. It is measured both with general free response questions and scaled questions reflecting frequency or lack thereof for a given issue (rated from Not during the past month to Three or more times a week).	2 weeks

Collaborators and Investigators

• Sponsor: The Methodist Hospital Research Institute
• Investigators: Principal Investigator: Patrick McCulloch, MD, The Methodist Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: April 19, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: CBD; Cannabidiol; Epidiolex
• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries; Rotator Cuff Injuries; Organic Chemicals; Hydrocarbons; Terpenes; Cannabinoids; Cannabidiol
• Other Study ID Numbers: PRO00036811

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No