Actively Recruiting
Cannabidiol for Postoperative Opioid Reduction in Primary Total Knee Arthroplasty A Randomized, Two by Two Factorial, Double-blind, Placebo-controlled Clinical Trial
Led by Chad Brummett · Updated on 2026-04-15
380
Participants Needed
2
Research Sites
N/A
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
Researchers are evaluating how daily treatment with cannabidiol (CBD) might affect the need for opioid pain medication, pain, inflammation, and related symptoms after knee replacement surgery. The study aims to better understand if CBD can reduce the use of opioids through its anti-inflammatory, pain-relieving, and anxiety-reducing effects. This is a phase 2, randomized, double-blind, placebo-controlled clinical trial focusing on patients undergoing primary total knee arthroplasty. Participants are divided into four groups. One group takes 300 mg of CBD daily (150 mg twice a day) for 36 days starting on the first day, another takes placebo for 7 days before surgery followed by CBD for 29 days after surgery, a third group takes CBD for 7 days before surgery then placebo for 29 days after, and the last group takes placebo throughout the 36 days. CBD is taken orally one hour before or two hours after meals. Dose adjustments are allowed for those who cannot tolerate the full dose. During the study, participants will be monitored for opioid use during the 28 days after surgery, pain intensity, anxiety, sleep disturbances, and inflammation markers. Researchers will collect data on adverse events, liver enzyme levels, and serious side effects over the five weeks of treatment. Follow-up includes patient-reported outcomes and longitudinal assessments to evaluate the impact of CBD on postoperative recovery and opioid consumption.
CONDITIONS
Brief 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 in English
- Willing to participate in all study measures including patient-reported outcomes and follow-up
- Scheduled for primary total knee arthroplasty surgery
- Primary diagnosis of osteoarthritis in the surgical knee
- Agree to use effective birth control if of reproductive potential and not donate sperm or eggs during study drug use
- Able and willing to take and swallow study medication and follow the treatment plan
- Agree to follow lifestyle considerations throughout the study duration
You will not qualify if you...
- Revision or bilateral total knee arthroplasty
- Receiving or applying for worker's compensation or disability benefits related to secondary gain
- Severe physical impairment or significant illness (e.g., blindness, paraplegia)
- Medical conditions affecting physical function (e.g., active non-skin cancer, recent organ transplant)
- Illicit drug use except cannabis; unreported opioid use
- Cannabis use within 7 days prior to study drug start or 8-30 days with failed drug screen or unconfirmed washout
- High daily preoperative opioid dose
- Major neurological disorders such as dementia, Parkinson's, epilepsy, or brain injury
- Significant illness or abnormal lab results that may affect participation
- Psychiatric conditions judged to prevent participation (excluding stable anxiety or depression)
- Pregnant or nursing women
- Liver cirrhosis, uncontrolled diabetes, active hepatitis
- High blood pressure or abnormal heart rate at screening
- Elevated liver enzymes or bilirubin beyond specified limits
- Severe cardiovascular diseases
- Current use of valproate, clobazam, warfarin, or strong CYP enzyme inducers
- Allergies to sesame oil, strawberries, opioids, or cannabis/cannabinoids
- Any impairment or condition preventing study completion
- Severe opioid side effects preventing opioid use after surgery
- Participation in other clinical trials during this study period except outside active periods
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 36 days
Participants take cannabidiol (CBD) or placebo before and/or after surgery to study its effect on postoperative opioid use.
Daily medication intake with visits during pre- and post-operative phases
Duration - 28 days after surgery
Participants are monitored for opioid consumption, pain, anxiety, sleep disturbance, and adverse events after surgery.
Visits during and after treatment to assess outcomes
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
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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