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New app and therapy aim to keep pregnant women on opioid treatment

NCT ID NCT06496230

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-stage study tested whether a brief therapy program plus a mobile app could help pregnant and postpartum women stay on their buprenorphine medication for opioid use disorder. Fifteen pregnant women took part, attending therapy sessions and using the app for up to 9 months. The goal was to see if the approach was practical and liked by participants, not to prove it works yet.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

15 people

The number who actually took part.

Started

Aug 2024

Finished

Jan 2026

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 less than 33 weeks gestational age, * 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 (i.e., twins, triplets, etc.); * High-risk pregnancies including the following conditions: hyperemesis defined as hospitalization for intractable nausea and vomiting, 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.

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Conditions

The condition(s) this trial relates to.

anxiety disorder opiate dependence pregnancy disorder 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 related

Contacts and locations

Locations

  • Medical University of South Carolina

    Charleston, South Carolina, 29403, United States

More trials for these conditions

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