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Single dose of methadone may ease pain after brain surgery

NCT ID NCT06810336

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares a single dose of methadone to the standard drug remifentanil for pain control after brain surgery. About 40 adults having elective brain surgery will be randomly assigned to one of the two drugs. The goal is to see if methadone provides better pain relief and recovery quality in the first few 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 it works, this could point toward a simpler, longer-lasting pain control method after brain surgery, reducing the need for other opioids.
What could go wrong
This is a very early, small trial with only 40 people, so results may not apply widely. Methadone also carries risks like respiratory depression.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Sep 2027

An estimate. End dates often move.

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 65 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. Adult Patients between ages 18 and 65 years old. 2. Undergoing supratentorial intracranial surgery 3. American Society of Anesthesiologists (ASA) physiological status I-III 4. Body Mass Index (BMI) between 18.5 and 45 5. Ability to understand and read English Exclusion Criteria: 1. Being unable or unwilling to sign a consent 2. Anticipated discharge within 24 hours after surgery 3. Patients requiring Emergent Surgery 4. Preoperative usage of Methadone, or allergy to it. 5. Patients with chronic pain, requiring daily opioid use at the time of surgery, MME \>60 as FDA defines opioid tolerant as 60 MME, long-acting forms of opioids such as fentanyl patch, oxycontin 6. Active or Prior Substance Use Disorder, undergoing active treatment with Medication of Opioid Use Disorder including methadone (once daily dosing), Buprenorphine (any formulation) and Naltrexone 7. Preoperative chronic renal insufficiency or failure (defined as a serum creatinine more than 2 mg/dl), 8. Pregnancy 9. Significant liver disease (cirrhosis or hepatic failure) 10. QTc \>450 on preoperative electrocardiogram 11. Pulmonary disease necessitating home oxygen therapy 12. Inability to speak or read the English language

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Conditions

The condition(s) this trial relates to.

brain cancer brain injury brain neoplasm Pain

As listed by the trial registrant

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

Brain injury Brain tumors Craniotomy surgery Pain Postoperative Postoperative care

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22908-0710, United States

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