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Cannabidiol for Bilateral Total Knee Arthroplasty

NCT04749628 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2025-02-06

No results posted yet for this study

Summary

In light of the opioid epidemic and evidence suggesting that cannabis may be opioid-sparing, we are in a unique position to conduct a novel, high-impact study that would set the stage for future RCTs examining the effects of a nonintoxicating and nonaddictive cannabinoid in an orthopedic patient population. Epidiolex®, an oral cannabidiol (CBD) solution, is the first ever cannabis-derived medication to be approved by the Food \& Drug Administration. Our aim is to conduct a pilot study using a placebo oral solution, 400mg and 800mg Epidiolex® to gather data on its effects on patients undergoing bilateral total knee arthroplasty (BTKA). We will be estimating whether Epidiolex® is associated with minimal opioid use and adequate analgesia. We will also assess its tolerability, pharmacokinetics, and effects on inflammatory markers in the perioperative setting.

Conditions

Interventions

DRUG

cannabidiol

Epidiolex (cannabidiol) oral solution

OTHER

Ora-sweet SF

Ora-sweet SF placebo

Sponsors & Collaborators

  • Hospital for Special Surgery, New York

    lead OTHER

Principal Investigators

  • Alexandra Sideris, PhD · Hospital for Special Surgery, New York

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-11-02
Primary Completion
2024-10-11
Completion
2025-01-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04749628 on ClinicalTrials.gov