Cannabidiol for Postoperative Opioid Reduction in Primary Total Knee Arthroplasty
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorChad Brummett
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Factorial
Treatments tested in this trial
Epidiolex oral solution
DrugParticipants assigned to CBD will take the medication one hour before or two hours after eating a meal. If participants can't tolerate the full-strength dose, the participant can decrease the dosing to 0.75 milliliter twice a day. If this is still not well tolerated, dosing can further be decreased to 0.75 milliliter once per day in the evening.
Placebo
Other interventionParticipants will be instructed to take one hour before or two hours after eating a meal.
Treatment groups
380 Participants
are divided into 4 treatment groupsGroup A: Pre - and post-operative CBDExperimental treatment 1 intervention
Group B: Pre-operative placebo plus post-operative CBDExperimental treatment 2 interventions
Group C: Pre-operative CBD plus post-operative placeboExperimental treatment 2 interventions
Group D: Pre- and post-operative placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Total postoperative opioid consumption (measured in oral morphine equivalents) during the 28 days after surgery
Time frame
28 days (after surgery)Secondary outcomes
1
The number of treatment-emergent adverse events (TEAEs)
Time frame
Five weeks of study treatment (Days 1 - 36)2
Proportion of participants with at least one treatment-emergent adverse events (TEAEs)
Time frame
Five weeks of study treatment (Days 1 - 36)3
The Number of serious adverse events (SAEs)
Time frame
Five weeks of study treatment (Days 1 - 36)4
Proportion of participants with at least one serious adverse event (SAE)
Time frame
Five weeks of study treatment (Days 1 - 36)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Chad Brummett
Lead sponsor
University of Michigan
Sponsor institution
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
Source ClinicalTrials.gov