Recruiting
Phase 1
Phase 2

CBD

Sponsor:

The Methodist Hospital Research Institute

Code:

NCT06381791

Conditions

Shoulder Osteoarthritis

Rotator Cuff Injuries

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Epidiolex

Placebo oral solution

Study Details

Brief 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

Conditions

Shoulder Osteoarthritis

Rotator Cuff Injuries

Study ID

NCT06381791

Start date

May 24, 2024

Status verified date

Apr, 2026

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Epidiolex

150mg of Epidiolex

Placebo oral solution

150mg of Placebo oral solution

Primary outcome measure

  • Primary - Pain Journal [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Haley M Goble, MPH, CRCC

7134413930hmgoble@houstonmethodist.org

David N Armond, BS

3462380206dnarmond@houstonmethodist.org

Locations

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Haley M Goble, MHA, CRCC

7134413930hmgoble@houstonmethodist.org

Principal Investigator:

Patrick C McCulloch, MD

More Information

Sponsor

The Methodist Hospital Research Institute

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Keywords

  • CBD
  • Cannabidiol
  • Epidiolex

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Methodist Hospital Research Institute on 2026-04-16.