Knee Replacement Surgery study: Epidiolex oral solution
Official title Cannabidiol for Postoperative Opioid Reduction in Primary Total Knee Arthroplasty
ClinicalTrials.gov ID: NCT06234631
What this study is testing
What is Epidiolex oral solution?
An investigational oral medication being studied for its potential to reduce opioid use and manage pain and inflammation after knee replacement surgery. It is designed to interact with the endocannabinoid system, which may influence pain perception and inflammation.
Also referred to as Cannabidiol.
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 taking CBD each day can lower the amount of opioid pain medicine needed after knee replacement, and how it affects pain, swelling, and other symptoms.
- Who it's for
- Adults who are having a primary total knee replacement for osteoarthritis.
- What's involved
- Participants will take a daily CBD dose and will have regular visits for pain and swelling assessments, and may receive standard care including opioids if needed.
- Time commitment
- The study lasts about 6 weeks after surgery, with several clinic visits to monitor pain, swelling, and medication use.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Willing and able to read, understand, and sign the informed consent (English)
- Willingness to participate in all study measures and restrictions, including patient-reported outcomes and longitudinal follow-up
- Scheduled for surgery: primary total knee arthroplasty
- Primary diagnosis of osteoarthritis of the surgical knee
- Individuals of reproductive potential must agree to use acceptable birth control (defined in manual of operating procedures).
You likely can't join if
- Revision or bilateral total knee arthroplasty
- Individuals receiving or actively applying for worker's compensation or disability and other aspects associated with potential secondary gain...
- Severe physical impairment or clinically significant illness (e.g., blindness, paraplegia)
- Co-morbid medical conditions that may significantly impair physical functional status (e.g., current non-skin malignancies, solid organ transplant in...
- Illicit drug use (other than cannabis). Unreported opioid use would be exclusionary but reported prescribed opioid use is allowed (e.g.
- Self-reported use of cannabis products within the 7 days prior to starting study drug
See the full eligibility criteria
- Willing and able to read, understand, and sign the informed consent (English)
- Willingness to participate in all study measures and restrictions, including patient-reported outcomes and longitudinal follow-up
- Scheduled for surgery: primary total knee arthroplasty
- Primary diagnosis of osteoarthritis of the surgical knee
- Individuals of reproductive potential must agree to use acceptable birth control (defined in manual of operating procedures).
- Participants must also agree not to donate sperm or eggs during study drug administration
- Ability to take and to swallow the study medication and be willing to adhere to the treatment regimen
- Agreement to adhere to Lifestyle Considerations (see protocol) throughout study duration
- Revision or bilateral total knee arthroplasty
- Individuals receiving or actively applying for worker's compensation or disability and other aspects associated with potential secondary gain (postoperative disability for recovery is permitted)
- Severe physical impairment or clinically significant illness (e.g., blindness, paraplegia)
- Co-morbid medical conditions that may significantly impair physical functional status (e.g., current non-skin malignancies, solid organ transplant in the past year)
- Illicit drug use (other than cannabis). Unreported opioid use would be exclusionary but reported prescribed opioid use is allowed (e.g. patient denies opioid use but is found to be positive on the urine drug screen)
- Self-reported use of cannabis products within the 7 days prior to starting study drug
- Self-reported use of cannabis products within the 8-30 days prior to starting study drug AND either a failed drug screen or inability to confirm successful washout (Note - may be rescreened with appropriate wash-out...
- High daily preoperative opioid dose
- Individuals with major neurological disorders, such as dementia, Parkinson's disease, cognitive impairment, epilepsy, history of traumatic brain injury/head injury, and seizures
- Individuals with significant illness (e.g., cancer) and/or clinically significant labs (e.g. labs measured by complete blood count (CBC) and basic chemistry with values meaningfully outside of the normal range [abnormal...
- Medical or psychiatric conditions that in the judgment of study personnel would preclude participation in this study (e.g., psychosis, suicidal ideation; note that stable anxiety and depression are not exclusions)
- Pregnant or nursing women (total joint arthroplasty is typically not indicated in this group of patients)
- Self-reported liver cirrhosis
- Self-reported uncontrolled diabetes
- Self-reported active hepatitis (any etiology, including infectious, autoimmune, or alcohol-related)
- Blood pressure at screening above 180 millimeters of mercury (mmHg) systolic and/or 120 mmHg diastolic
- Resting heart rate at screening less than 50 beats per minute (bpm) or greater than 100 bpm; if value exceeds the set point, potential participants will have repeat assessment within 5 minutes for up to two additional...
- Elevated liver enzymes and bilirubin (measured by blood test at screening)
- Serum total bilirubin ≥ 2.5 milligrams (mg) per deciliter (dL) (mg/dL); or,
- Alanine transaminase (ALT) or Alanine transaminase (AST) ≥ 3x upper limit normal (ULN); or,
- Alkaline phosphatase ≥ 2x ULN
- Severe cardiovascular disease (e.g., current unstable angina, current congestive heart failure, or current severe valvular abnormalities) that is self-reported by patient or in medical record
- Current valproate, clobazam, or warfarin use per self-report or medical records
- Current use of strong inducers of cytochrome p450 (CYP) enzymes CYP3A4 and CYP2C19, or CYP2C19 substrates with a narrow therapeutic index
- Self-reported allergies to sesame oil, strawberries, opioids, or cannabis/cannabinoids and confirmed by the investigator during screening
- Any impairment, activity, behavior, or situation that in the judgment of the study team would prevent satisfactory completion of the study protocol
- Self-reported severe side effects to opioids precluding the use of opioids for post-surgical pain and/or clear plan not to use any opioids after surgery and confirmed by the investigator during screening
- Participation in other clinical trials over the course of this study (note: outside of active period is permissible as determined by the investigator during screening)
The study team makes the final eligibility decision.
Where it is enrolling
- Ann Arbor, Michigan, United States
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
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 to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Ann Arbor, Michigan, 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.