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New treatment option for Knee Replacement Surgery
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?
Epidiolex oral solution is an investigational medicine, given as an once-daily, being studied as a potential treatment for knee replacement surgery.
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 goal of this study is to better understand how daily treatment with cannabidiol (CBD) affects the need for opioid pain medication, as well as pain, inflammation and other related symptoms, after knee replacement surgery. The information collected in this study is necessary to help understand whether CBD may be a useful medication before and/or after surgery.
- 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). This includes currently...
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. patient...
- 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). This includes currently practicing an effective form of two types of birth control for women...
- 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; if value exceeds the set point, potential participants will have repeat assessment within 5 minutes for up to two...
- 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's taking place
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
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 - 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 - 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?
Study sites include Ann Arbor, Michigan, United States; Detroit, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.