Dosing of Methadone for Spine Surgery

Stopped early · Phase 2

Conditions studied: Pain, Postoperative

In brief

This study compares two methods of dosing methadone for complex spine cases

Key facts

Study ID

NCT03605901

Run by

University of Florida

People needed

21

Starts

2019-03-19

Expected to finish

2025-05-09

Last updated by the study team

2026-06-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must consent to participate and sign the IRB-approved informed consent prior to beginning any study specific procedures.
• At or between the ages 18 to 75 years.
• Undergoing multilevel thoracic, thoracolumbar and/or lumbar spine surgery with instrumentation and fusion.

You may not qualify if…

• Methadone or buprenorphine use.
• Morbid obesity with BMI>40 Kg/m2.
• Chronic renal failure with creatinine>2.0 mg/dL.
• Liver failure as determined by cirrhosis or history of fulminant hepatic failure.
• Current or historical alcohol abuse.
• Current or historical drug abuse.
• Patients with history of prolonged QTc, as defined as a QTc value >450 ms in males and >460 ms in females.
• Patients with ASA status IV or V.
• Surgical diagnosis including spine tumor, infection, or trauma.
• In the Principal Investigator's opinion is not a candidate for the study.
• Unwilling to sign the informed consent form.

Where it is running

• UF Health — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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