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New program aims to help pregnant women with opioid addiction and their babies

NCT ID NCT05609669

Disease control Sponsor: University of South 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a program that connects pregnant women with opioid use disorder to a team of doctors, peer supporters, and community resources like doulas and home visiting. The goal is to improve treatment during pregnancy and reduce the need for medication in newborns experiencing withdrawal. Only 10 participants are enrolled, so this is an early test of the program's feasibility.

What this could mean

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

Active substance
Integrated care program (peer support, care navigation, community resources)
What this could lead to
If successful, this could show that coordinated care helps more mothers stay on treatment and reduces the need for medication in newborns with withdrawal.
What could go wrong
This is a very small pilot study (10 participants) with no control group, so results may not be generalizable. The program's success depends on community resources that may not be available elsewhere.

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 10 people

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

Started

Aug 2023

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 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: * Patients with known opioid use disorder over the age of 18 years old who are pregnant Exclusion Criteria: * Patients without opioid use disorder, less than 18 years old, incarcerated, or non-pregnant

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Conditions

The condition(s) this trial relates to.

opiate dependence pregnancy disorder

As listed by the trial registrant

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

Opioid-use disorder Pregnancy related

Contacts and locations

Locations

  • University of South Florida/Tampa General Hospital

    Tampa, Florida, 33606, United States

More trials for these conditions

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