Actively Recruiting
Cannabidiol for Postoperative Opioid Reduction in Primary Total Knee Arthroplasty
Led by Chad Brummett · Updated on 2026-04-15
380
Participants Needed
2
Research Sites
250 weeks
Total Duration
On this page
Sponsors
C
Chad Brummett
Lead Sponsor
N
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cannabidiol for Postoperative Opioid Reduction in Primary Total Knee Arthroplasty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 from screening until 28 days after last study drug administration
- Participants must agree not to donate sperm or eggs during study drug administration
- Ability to take and swallow the study medication and willingness to follow treatment regimen
- Agreement to adhere to lifestyle considerations throughout study duration
You will not qualify if you...
- Revision or bilateral total knee arthroplasty
- Receiving or applying for worker's compensation or disability related to potential secondary gain
- Severe physical impairment or clinically significant illness (e.g., blindness, paraplegia)
- Co-morbid conditions impairing physical function (e.g., current non-skin malignancies, recent organ transplant)
- Illicit drug use other than cannabis; unreported opioid use excluded
- Cannabis use within 7 days prior to study drug start
- Cannabis use within 8-30 days prior with failed drug screen or no confirmed washout
- High daily preoperative opioid dose
- Major neurological disorders (e.g., dementia, Parkinson's, epilepsy, brain injury)
- Significant illness or abnormal lab values outside normal range
- Medical or psychiatric conditions precluding participation (e.g., psychosis, suicidal ideation)
- Pregnant or nursing women
- Self-reported liver cirrhosis, uncontrolled diabetes, or active hepatitis
- Blood pressure over 180/120 mmHg or resting heart rate under 50 or over 100 bpm at screening
- Elevated liver enzymes or bilirubin above specified limits
- Severe cardiovascular disease
- Current use of valproate, clobazam, warfarin, or strong CYP enzyme inducers
- Allergies to sesame oil, strawberries, opioids, or cannabis
- Any impairment or situation preventing study completion
- Severe opioid side effects precluding opioid use after surgery
- Participation in other clinical trials during this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
2
Henry Ford Health System
Detroit, Michigan, United States, 48202
Not Yet Recruiting
Research Team
K
Kendall Dubois
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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