Cannabidiol for Opioid Reduction After Knee Replacement Surgery
This study is investigating whether daily treatment with Epidiolex oral solution (a form of cannabidiol or CBD) can help reduce the need for opioid pain medication after total knee replacement surgery. Researchers also want to understand how CBD affects pain, inflammation, and other symptoms. You may be able to join if you are between 18 and 80 years old, have osteoarthritis, and are scheduled for a primary total knee replacement. Participants will receive either Epidiolex or a placebo (an inactive substance) and will be monitored for 28 days after surgery to see how much opioid pain medication they use. The study aims to determine if CBD can be a useful medication before and/or after surgery. The current recruitment status is unclear.
- Study design
- This study plans to enroll 380 participants. Participants will be randomly assigned to receive either Epidiolex oral solution or a placebo.
- What's involved
- Participants will take their assigned medication daily and complete patient-reported outcomes and follow-up measures. The primary endpoint for opioid consumption is measured 28 days after surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 28 days after surgery to measure total postoperative opioid consumption.
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NCT06234631
Cannabidiol for Postoperative Opioid Reduction in Primary Total Knee Arthroplasty
Recruiting
PHASE2Ages 18–80InterventionalTreatmentChad BrummettInvestigator-initiated
~380 participants
Updated 2026-04-15 on ClinicalTrials.gov
What's tested:Epidiolex oral solutionPlacebo
At a glance
Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Total postoperative opioid consumption (measured in oral morphine equivalents) during the 28 days after surgery
Measured over 28 days (after surgery)
Conditions
Where it's being run
2 sites across 1 statesMichigan2
Study leadership
- Chad Brummett, MD · PRINCIPAL_INVESTIGATOR · University of Michigan
- Kevin F Boehnke · PRINCIPAL_INVESTIGATOR · University of Michigan
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 of childbearing potential, which are defined as those, alone or in combination, that result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly from the screening visit until 28 days after the last study drug administration.
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
Exclusion
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 period)
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 \[abnormal levels to be reviewed by the Principal Investigator or prescribing provider\])
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 additional measurements.
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 measurements.
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)
What this trial measures
- Total postoperative opioid consumption (measured in oral morphine equivalents) during the 28 days after surgery28 days (after surgery)