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Cannabidiol for Postoperative Opioid Reduction in Primary Total Knee Arthroplasty

NCT06234631 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2026-04-15

No results posted yet for this study

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.

Conditions

  • Knee Replacement Surgery
  • Osteoarthritis, Knee

Interventions

DRUG

Epidiolex oral solution

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.

OTHER

Placebo

Participants will be instructed to take one hour before or two hours after eating a meal.

Sponsors & Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    collaborator NIH

  • Chad Brummett

    lead OTHER

Principal Investigators

  • Chad Brummett, MD · University of Michigan

  • Kevin F Boehnke · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-13
Primary Completion
2029-01-31
Completion
2029-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06234631 on ClinicalTrials.gov