TerminatedPhase 2

Dosing of Methadone for Spine Surgery

Stopped: PI left institution.

United States21 participantsStarted 2019-03-19

Plain-language summary

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

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Opioid Requirement for Complex Spine Surgery Patients 24, 48, and 72 Hours Postop

Timeframe: Postop 24 hours, Postop 48 hours, Postop 72 hours

Trial details

NCT IDNCT03605901

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-09

Results submitted2026-04-23

View on ClinicalTrials.gov More Pain, Postoperative trials