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New model aims to treat opioid use disorder in mothers right at their baby's hospital bedside

NCT ID NCT06576323

Disease control Sponsor: University of Pennsylvania 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This study aims to create a way for mothers with opioid use disorder to receive treatment (buprenorphine) while visiting their babies in the neonatal intensive care unit (NICU). Researchers will interview mothers and healthcare providers to understand barriers and then develop a practical care model. The goal is to make it easier for mothers to get help and improve outcomes for both mother and infant.

What this could mean

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

Active substance
buprenorphine
What this could lead to
If successful, this could create a practical way to treat opioid use disorder in new mothers while they are at their baby's bedside in the NICU, improving health for both.
What could go wrong
This is a small, early-stage study focused on developing and testing the feasibility of a care model, not on proving it works. It may not be widely adopted or show clear health benefits.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

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

Started

Jul 2024

Expected to finish

May 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 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 for Interview Participants in Aim 1: * Participants should be healthcare providers working within UPHS, who generally treat perinatal women or any individuals with OUD; for the purposes of this study, provider refers to a Medical Doctor (MD) or Doctor of Osteopathy (DO), Advanced Practice Practitioner, Nurse, or Social Worker. * Participants should provide direct care to NICU patients and/or their mothers * Participants should be proficient in English language * Participants should have access to a computer with internet connectivity or phone Inclusion Criteria for Mothers in Aim 1: * Participants should be biological mothers of children hospitalized in the UPHS NICU for NAS * Participants should be diagnosed with opioid use disorder Inclusion Criteria for Clinicians in Aim 3: * See above for inclusion criteria for interview participants. * We will use this same criteria to recruit new participants for Aim 3 if the same stakeholder interviewees are unavailable at the time of Aim 3. Inclusion Criteria for Mothers in Aim 3: * Participants should be biological mothers of a child hospitalized in either of the two UPHS NICU for NAS (either HUP or PAH) * Participants should be no more than 4 weeks postpartum * Participants should have an Opioid Use Disorder than is currently untreated with medication assisted treatment or buprenorphine Exclusion Criteria for Interview Participants in Aim 1: \- None Exclusion Criteria for Mothers in Aim 1: \- None Exclusion Criteria for Clinicians in Aim 3: \- None Exclusion Criteria for Mothers in Aim 3: \- Active suicidal ideation, or other severe psychopathology that must be addressed before effective MOUD can be prescribed

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Conditions

The condition(s) this trial relates to.

neonatal abstinence syndrome opiate dependence

As listed by the trial registrant

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

Neonatal abstinence syndrome Opioid-use disorder

How to take part

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

  1. The places running it

    3 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

  • Hospital of the University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Penn Center for Women's Behavioral Wellness

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Pennsylvania Hospital

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

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