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CBD for Pain After Shoulder Surgery

This study is looking into whether Epidiolex (a cannabidiol medication) can help reduce pain after orthopedic shoulder surgery. Researchers want to see if Epidiolex, given in addition to standard pain medication, is effective and safe. They will compare 150mg of Epidiolex to a placebo (an inactive solution) in 80 participants. You may be able to join if you are over 18, having rotator cuff repair surgery, and using effective birth control if you can become pregnant. The main goal is to measure your pain levels using a pain journal for two weeks after surgery. The study status is currently unclear.

Study design
This is an interventional study planning to enroll 80 participants. You will be randomly assigned to receive either Epidiolex or a placebo.
What's involved
You will track your pain daily for two weeks, complete two surveys (before and after surgery), and have bloodwork done after surgery. A researcher will call you weekly for check-ups.
Compensation
Not stated in the trial record.
Follow-up
You will track your pain for two weeks after surgery, and there will be safety monitoring calls up to one week after completing treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06381791

CBD for Pain Following Orthopedic Shoulder Surgery

Recruiting
PHASE1Ages 18+InterventionalTreatment
The Methodist Hospital Research Institute
~80 participants
Updated 2026-04-16 on ClinicalTrials.gov
What's tested:EpidiolexPlacebo oral solution

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary - Pain Journal
Measured over 2 weeks

Conditions

Shoulder Osteoarthritis
Rotator Cuff Injuries

Explore related trials

Injury of rotator cuffOsteoarthritis of glenohumeral joint

Where it's being run

1 sites across 1 states
Texas1

Study leadership

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

Who to contact

Haley M Goble, MPH, CRCC
[email protected]
7134413930
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Primary - Pain Journal2 weeks

    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.