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CBD for Post-Surgery Shoulder Pain (CBD Trial)

Phase 1 & 2
Recruiting
Led By Patrick McCulloch, MD
Research Sponsored by The Methodist Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Receiving standard anesthesia during surgery
Undergoing one of the following orthopedic shoulder surgeries: Total shoulder arthroplasty, Reverse total shoulder arthroplasty, Shoulder hemiarthroplasty, Rotator cuff repair
Must not have
Currently taking central nervous system (CNS) depressants
Not between the ages of 18-55 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks

Summary

"This trial aims to investigate if Epidiolex (cannabidiol) can be used as an additional pain medication for patients who have undergone orthopedic shoulder surgery. The study will also focus

Who is the study for?
This trial is for individuals with shoulder osteoarthritis or rotator cuff injuries who are undergoing orthopedic surgery. Participants must be willing to track their pain daily, complete surveys before and after surgery, and have bloodwork done post-surgery.
What is being tested?
The study aims to determine if Epidiolex (cannabidiol) can help manage pain as an additional medication following shoulder surgery. It will compare the effects of Epidiolex with a placebo by monitoring participants' reported pain levels and medication use.
What are the potential side effects?
Potential side effects of Epidiolex may include drowsiness, changes in appetite, diarrhea, fatigue, malaise, weakness, sleeping problems, poor quality sleep and infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I will be given standard anesthesia during my surgery.
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I am having shoulder surgery, such as joint replacement or rotator cuff repair.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently on medication that affects my brain's activity.
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I am younger than 18 or older than 55.
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I have had a shoulder replacement surgery redone.
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I am currently taking medication known to affect the liver.
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I have a history of liver problems.
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I am currently on medication that strongly affects liver enzymes.
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I am currently taking valproate or clobazam.
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I am currently using prescription pain medication.
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I am not on medications known to increase the risk of suicidal thoughts.
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I have been diagnosed with a mental health or sleeping disorder.
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I am currently on medication that strongly affects liver enzymes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary - Pain Journal
Secondary study objectives
Pain Disability Index (PDI)
Pain, Enjoyment, General Activity (PEG) Scale
Patient Health Questionnaire 4 (PHQ-4): The four-item patient health questionnaire for anxiety
+2 more

Side effects data

From 2022 Phase 1 & 2 trial • 3 Patients • NCT04238754
67%
Abdominal Pain
33%
Drowsiness
33%
Headache
33%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Epidiolex
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Epidiolex (cannabidiol)Experimental Treatment1 Intervention
Patients randomized to the Epidiolex group will take 150mg of Epidiolex with food twice daily for 14 days beginning the day of surgery.
Group II: PlaceboPlacebo Group1 Intervention
Patients randomized to the placebo group will take 150mg of oral placebo solution with food for 14 days beginning the day of surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Epidiolex
2023
Completed Phase 2
~530

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteLead Sponsor
285 Previous Clinical Trials
81,606 Total Patients Enrolled
Patrick McCulloch, MDPrincipal InvestigatorThe Methodist Hospital Research Institute
3 Previous Clinical Trials
448 Total Patients Enrolled
~53 spots leftby Dec 2026
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