Cannabidiol for Postoperative Opioid Reduction in Primary Total Knee Arthroplasty

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
Chad Brummett
Study ID
NCT06234631
Phase
PHASE2
Status
Recruiting
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Conditions

  • Knee Replacement Surgery
  • Osteoarthritis, Knee

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Epidiolex oral solution — DRUG
    Participants 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
    Participants will be instructed to take one hour before or two hours after eating a meal.

Study Details

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.

Key Dates

Start date
Mar 13, 2024
Status verified
Apr 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2029

Study Design

Enrollment
380 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Pre - and post-operative CBD
    Participants will take 300 milligrams (mg)/day on days 1-36 (150mg twice a day \[b.i.d.\])
  • Experimental: Pre-operative placebo plus post-operative CBD
    Participants will take placebo prior to surgery days 1-7, then days 8-36 participants will take CBD 300 milligrams (150mg twice a day \[b.i.d.\])
  • Experimental: Pre-operative CBD plus post-operative placebo
    Participants will take CBD 300 milligrams (mg) /day prior to surgery on days 1-7 (150mg twice a day \[b.i.d.\]), then days 8-36 will take placebo twice a day \[b.i.d.\]
  • Placebo Comparator: Pre- and post-operative placebo
    Participants will take placebo on days 1-36 twice a day \[b.i.d.\]

Primary Outcome Measure

Total postoperative opioid consumption (measured in oral morphine equivalents) during the 28 days after surgery [ Time Frame: 28 days (after surgery) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Kendall Dubois
[email protected]
734-232-0324
Chad Brummet, MD (PRINCIPAL_INVESTIGATOR)
Henry Ford Health SystemDetroitMichigan48202
Katherine Nowak
313-771-7128
Lara Zador, MD
[email protected]
Lara Zador, MD (PRINCIPAL_INVESTIGATOR)

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