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Can a phone app help pregnant women stick with addiction treatment?

NCT ID NCT06999811

Disease control Sponsor: Medical University of South Carolina 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a special therapy program with a mobile app helps pregnant people stay on their buprenorphine medication for opioid use disorder, compared to just logging their doses. About 37 pregnant women will be randomly assigned to either the app-based therapy or daily medication tracking. The goal is to see if the extra support improves treatment retention and engagement.

What this could mean

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

Active substance
behavioral intervention (EMPWR) with mobile app
What this could lead to
If successful, this could show that a therapy app plus counseling helps pregnant people stick with their opioid treatment, improving health for mother and baby.
What could go wrong
This is a very small early feasibility study (37 people), so results may not apply widely. The therapy is extra work and may not improve retention over simple monitoring.

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 37 people

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

Started

Nov 2025

Expected to finish

Oct 2028

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 45 years

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: * currently pregnant and between 13 weeks and 0 days to 32 weeks and 6 days gestational age * current OUD or history of OUD within past 3 years * confirmed prescription for sublingual buprenorphine products (i.e., Suboxone, Subutex, Zubsolv) for the purpose of treating OUD * living in the United States * between 18-45 years of age Exclusion Criteria: * carrying multiples * high-risk pregnancies including the following conditions: active hyperemesis at the time of consent or hospitalization for intractable nausea and vomiting in the current pregnancy, hypertensive disorders of pregnancy (e.g., gestational hypertension, preeclampsia), placenta previa, or vaginal bleeding in current pregnancy after the first trimester * current psychotic symptoms and/or active suicidal intent * experiencing cognitive or emotional impairment that precludes providing informed consent * incarcerated/pending incarceration or institutionalized during the study period * non-English speaking.

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Conditions

The condition(s) this trial relates to.

anxiety disorder opiate dependence Psychological Well-Being sleep-wake disorder substance-related disorder

As listed by the trial registrant

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

Opioid use disorder Pregnancy

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

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29403, United States

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