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Epidiolex (cannabidiol) for Shoulder Osteoarthritis (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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks

Awards & highlights

CBD Trial 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.Check my eligibility

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.See study design

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.

CBD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I will be given standard anesthesia during my surgery.

Select...

I am having shoulder surgery, such as joint replacement or rotator cuff repair.

CBD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary - Pain Journal

Secondary outcome measures

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%

Nausea

33%

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Epidiolex

Placebo

CBD 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

2020

Completed Phase 2

~380

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteLead Sponsor

275 Previous Clinical Trials

80,465 Total Patients Enrolled

Patrick McCulloch, MDPrincipal InvestigatorThe Methodist Hospital Research Institute

3 Previous Clinical Trials

448 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current sample size of participants in this research study?

"Affirmative. The details on clinicaltrials.gov imply that this study is presently enrolling participants. Initially released on May 1, 2024, and most recently revised on April 19, 2024, the trial aims to recruit a total of 80 individuals from one location."

Answered by AI

Is the enrollment process open for this medical study at present?

"Indeed, as per details on clinicaltrials.gov, this research is actively enrolling subjects. The study was initially posted on May 1st, 2024 and last revised on April 19th, 2024. It aims to recruit 80 individuals from a single site."

Answered by AI

Are participants in this study limited to individuals who have reached the age of 18 or older?

"Applicants eligible for this trial should fall within the age bracket of 18 to 55. There are separate studies available, with seven focusing on pediatric patients under 18 years old and an additional 131 trials targeting individuals over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CBD for Pain Following Orthopedic Shoulder Surgery

Patrick McCulloch,MD 2024. "CBD for Pain Following Orthopedic Shoulder Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06381791.

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