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Cannabinoid

CBD Oil for Postoperative Pain (CBDS Trial)

Phase < 1
Recruiting
Research Sponsored by Foundation for Orthopaedic Research and Education
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Requiring shoulder arthroscopic surgery for soft tissue pathology
Age 18 years or older
Must not have
Shoulder dislocation
Younger than 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days preoperatively leading up to surgery then 30 days postoperatively as well. outcomes will be collected from surgery to 6 weeks postoperatively.
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

This trial will compare the effectiveness of CBD oil to opioids in controlling post-operative pain.

Who is the study for?
This trial is for adults over 18 needing shoulder arthroscopic surgery due to soft tissue issues. Participants must be able to complete surveys and follow-up visits. It's not for those under 18, with a history of shoulder dislocation or fracture, previous shoulder surgeries, other limb problems, or who are pregnant.
What is being tested?
The study compares the effectiveness of CBD oil versus traditional opioid medications in managing pain after elective shoulder arthroscopy. It's a forward-looking (prospective), randomized trial where patients don't know which treatment they're getting.
What are the potential side effects?
While specific side effects aren't listed here, generally CBD oil may cause tiredness, changes in appetite/weight, diarrhea; opioids can lead to nausea, constipation, drowsiness and risk of dependency.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I need shoulder surgery for a soft tissue problem.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a shoulder dislocation.
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I am under 18 years old.
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I have a shoulder fracture.
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I have had shoulder surgery before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days preoperatively leading up to surgery then 30 days postoperatively as well. outcomes will be collected from surgery to 6 weeks postoperatively.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days preoperatively leading up to surgery then 30 days postoperatively as well. outcomes will be collected from surgery to 6 weeks postoperatively. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Post-operative pain
Secondary study objectives
Sleep Quality

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Cannabidiol Oil 200 mgExperimental Treatment1 Intervention
CBD 200 mg PO liquid suspension QD starting 30 days prior and finishing 30 days post-op
Group II: Cannabidiol Oil 100 mgExperimental Treatment1 Intervention
CBD 100 mg PO liquid suspension QD starting 30 days prior and finishing 30 days post-op
Group III: Standard of CareActive Control1 Intervention
Opioid standard of care: Tramadol 50 mg PO PRN #30, Hydrocodone/Acetaminophen 5/325 PO PRN #30
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabidiol
FDA approved

Find a Location

Who is running the clinical trial?

Foundation for Orthopaedic Research and EducationLead Sponsor
14 Previous Clinical Trials
951 Total Patients Enrolled

Media Library

Cannabidiol Oil (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05240755 — Phase < 1
Pain Research Study Groups: Standard of Care, Cannabidiol Oil 100 mg, Cannabidiol Oil 200 mg
Pain Clinical Trial 2023: Cannabidiol Oil Highlights & Side Effects. Trial Name: NCT05240755 — Phase < 1
Cannabidiol Oil (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05240755 — Phase < 1
~2 spots leftby Feb 2025