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New study tests coaching for pregnant women battling opioid addiction

NCT ID NCT07586917

Disease control Sponsor: University of Utah 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Updated 3 times

Summary

This study tests whether patient navigation—a series of coaching sessions—helps pregnant women with opioid use disorder stay in treatment and reduce drug use. About 429 pregnant women will be randomly assigned to either usual care or patient navigation, which includes up to 14 sessions. The goal is to see if this support improves medication adherence and connects them to services.

What this could mean

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

Active substance
Patient Navigation (behavioral intervention)
What this could lead to
If it works, this could show that patient navigation helps pregnant women with opioid use disorder stay in treatment and reduce substance use, improving outcomes for mothers and babies.
What could go wrong
This is a behavioral study with no drug being tested, so it won't cure addiction. Results may vary by individual, and the intervention requires time and commitment from participants.

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 429 people

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

Started

Jul 2026

Expected to finish

Jun 2030

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: * Adult (≥18 years) * Opioid use disorder * ≥7 weeks gestation * Medication for opioid use disorder naive or newly initiated (≤6 weeks MOUD) * Provide permission to access administrative claims and medical records of their care and those of their neonate * Speak English Exclusion Criteria: * Plan to terminate pregnancy * Had a psychotic and/or manic episode in the last 30 days * Cannot provide contact information for themselves and 2 collateral contacts * Do not possess a reliable phone * Plan to move from the area ≤6 months of delivery * \>32 weeks gestation

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Conditions

The condition(s) this trial relates to.

opiate dependence opioid abuse

As listed by the trial registrant

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

Opioid abuse (disorder) Stimulant use disorders

How to take part

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

  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

    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

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84108, United States

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