NCT06234631 Cannabidiol for Postoperative Opioid Reduction in Primary Total Knee Arthroplasty
| NCT ID | NCT06234631 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Chad Brummett |
| Condition | Knee Replacement Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 380 participants |
| Start Date | 2024-03-13 |
| Primary Completion | 2029-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 380 participants in total. It began in 2024-03-13 with a primary completion date of 2029-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. The study hypothesis is that CBD exerts opioid-sparing effects through anti-inflammatory, analgesic, and anxiolytic mechanisms.
Eligibility Criteria
Inclusion 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 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 Criteria: * 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)
Contact & Investigator
Chad Brummett, MD
PRINCIPAL INVESTIGATOR
University of Michigan
Frequently Asked Questions
Who can join the NCT06234631 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Knee Replacement Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06234631 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06234631 currently recruiting?
Yes, NCT06234631 is actively recruiting participants. Contact the research team at kendalld@med.umich.edu for enrollment information.
Where is the NCT06234631 trial being conducted?
This trial is being conducted at Ann Arbor, United States, Detroit, United States.
Who is sponsoring the NCT06234631 clinical trial?
NCT06234631 is sponsored by Chad Brummett. The principal investigator is Chad Brummett, MD at University of Michigan. The trial plans to enroll 380 participants.