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One shot of methadone during surgery could slash opioid prescriptions

NCT ID NCT06536517

Symptom relief Sponsor: Johns Hopkins University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether giving a single dose of methadone during laparoscopic or robotic hysterectomy can reduce the need for opioid painkillers after surgery. About 100 women with non-cancerous fibroids will be randomly assigned to receive either methadone or standard short-acting opioids during the procedure. The goal is to see if this approach lowers total opioid use in the first week after surgery, helping to prevent overprescription and potential abuse.

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 way to manage post-surgery pain with fewer opioid pills, lowering the risk of addiction.
What could go wrong
This is a small, early-phase trial (100 people) testing a single dose. Methadone itself is an opioid, so it may not reduce overall opioid use or could cause side effects like nausea or drowsiness.

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

About 100 people

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

Started

Mar 2025

Expected to finish

Dec 2026

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 years and older

Sex

Female participants only

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: * Individuals with a uterus * Age 18 years old and above * Undergoing minimally invasive (laparoscopic or robotic) hysterectomy with ovarian preservation * Benign indications for hysterectomy * Agreeing to participate Exclusion Criteria: * Chronic pain syndromes patients including fibromyalgia * Patients currently on long-term (i.e. for more than three months) opioid use * Patients currently on agonist-antagonist medications (e.g. buprenorphine) * Patients taking a selective serotonin reuptake inhibitor or monoamine oxidase inhibitor * Conversion to laparotomy * Allergy or other contraindication to the prescribed medications such as methadone, fentanyl, acetaminophen or oxycodone * Severe Obstructive Sleep Apnea (OSA) * Pregnant/breastfeeding patients

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Conditions

The condition(s) this trial relates to.

leiomyoma uterine corpus leiomyoma

As listed by the trial registrant

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

Fibroid uterus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. 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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Johns Hopkins Bayview Medical Center

    RECRUITING

    Baltimore, Maryland, 21224, United States

  • The Johns Hopkins Hospital

    RECRUITING

    Baltimore, Maryland, 21287, United States

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