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Could a better methadone dose cut opioid use after spine surgery?

NCT ID NCT03605901

Symptom relief Sponsor: University of Florida Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests two methods of giving methadone to adults undergoing complex spine surgery. One group gets a standard dose based on body weight, while the other receives smaller, incremental doses until breathing slows. The goal is to see which approach reduces the need for additional painkillers in the days after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
methadone
What this could lead to
If one dosing method proves better, it could help manage pain after spine surgery with fewer opioids.
What could go wrong
This is a small, early-phase study with only 21 participants, so results may not apply to everyone. Methadone carries risks like breathing problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

21 people

The number who actually took part.

Started

Mar 2019

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients must consent to participate and sign the IRB-approved informed consent prior to beginning any study specific procedures. 2. At or between the ages 18 to 75 years. 3. Undergoing multilevel thoracic, thoracolumbar and/or lumbar spine surgery with instrumentation and fusion. Exclusion Criteria: 1. Methadone or buprenorphine use. 2. Morbid obesity with BMI\>40 Kg/m2. 3. Chronic renal failure with creatinine\>2.0 mg/dL. 4. Liver failure as determined by cirrhosis or history of fulminant hepatic failure. 5. Current or historical alcohol abuse. 6. Current or historical drug abuse. 7. Patients with history of prolonged QTc, as defined as a QTc value \>450 ms in males and \>460 ms in females. 8. Patients with ASA status IV or V. 9. Surgical diagnosis including spine tumor, infection, or trauma. 10. In the Principal Investigator's opinion is not a candidate for the study. 11. Unwilling to sign the informed consent form.

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Conditions

The condition(s) this trial relates to.

Pain, Postoperative

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pain, postoperative

Contacts and locations

Locations

  • UF Health

    Gainesville, Florida, 32610-3003, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.