Shoulder Osteoarthritis study: Epidiolex
Official title CBD for Pain Following Orthopedic Shoulder Surgery
ClinicalTrials.gov ID: NCT06381791
What this study is testing
What is Epidiolex?
an investigational oral cannabidiol solution being studied as an additional pain medication for shoulder osteoarthritis after orthopedic shoulder surgery is designed to interact with the body's endocannabinoid system, which may help modulate pain signals
Also referred to as Cannabidiol Oral Solution.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out if CBD can reduce pain after shoulder surgery and what dose is safe, while watching for side effects.
- Who it's for
- Adults who are having orthopedic shoulder surgery for osteoarthritis or rotator‑cuff injuries.
- What's involved
- You will be randomly given either CBD (Epidiolex) or a placebo, keep a daily pain diary, answer two short surveys (one before and one after surgery), receive weekly phone check‑ins, and have a blood test after surgery.
- Time commitment
- The study runs for several weeks after surgery with weekly phone calls and a few clinic visits for surveys and blood work.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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
See the full eligibility criteria
- 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.
- 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. Patients taking concomitant medications which are substrate of uridine 5'-diphospho-glucuronosyltransferase 1-9 (UGT1A9), uridine diphosphate-glucuronosyltransferase 2B7 (UGT2B7), CYP1A2, CYP2B6...
The study team makes the final eligibility decision.
Where it is enrolling
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.