Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT06381791

CBD for Pain Following Orthopedic Shoulder Surgery

Led by The Methodist Hospital Research Institute · Updated on 2026-04-16

80

Participants Needed

1

Research Sites

187 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

CBD for Pain Following Orthopedic Shoulder Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Above the age of 18 years old
  • Undergoing a rotator cuff repair surgery
  • Receiving standard anesthesia during surgery
  • If of reproductive potential, using effective contraception one month before, during, and one month after treatment
Not Eligible

You will not qualify if you...

  • Under the age of 18 years old
  • History of revision shoulder arthroplasty
  • History of liver disease or impairment
  • Currently taking valproate or clobazam
  • Currently taking moderate or strong CYP3A4 or CYP2C19 inhibitors
  • Currently taking strong CYP3A4 or CYP2C19 inducers
  • Currently taking narcotics
  • History of substance or alcohol abuse
  • Currently or previously under care of a pain management specialist
  • History of regular marijuana or cannabidiol use (not topical) within the past 6 months
  • Allergy to cannabidiol
  • Allergy to sesame seeds
  • Pregnant (negative pregnancy test required before surgery)
  • Taking medications with known risks for suicidal behavior or ideation
  • Diagnosed psychiatric disorder
  • Untreated diagnosed sleeping disorder
  • Actively breastfeeding
  • Currently taking central nervous system depressants
  • Taking other drugs with known liver toxicity
  • Vulnerable populations
  • Taking medications metabolized by UGT1A9, UGT2B7, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or P-gp will be monitored for possible side effects

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Houston Methodist Hospital

Houston, Texas, United States, 77030

Actively Recruiting

Loading map...

Research Team

H

Haley M Goble, MPH, CRCC

CONTACT

D

David N Armond, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here