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Opioid treatment in pregnancy: which form is safer for Baby's brain?

NCT ID NCT03911739

Knowledge-focused Sponsor: T. John Winhusen, PhD 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at 71 babies born to mothers who took either a monthly injection or a daily tablet of buprenorphine for opioid use disorder during pregnancy. Researchers measured the babies' thinking, language, and motor skills using a standard child development test. The goal was to see if the longer-acting injection leads to better brain development than the daily tablet.

What this could mean

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

Active substance
buprenorphine (extended-release injection or daily sublingual tablet)
What this could lead to
If it works, this could help doctors choose the safest opioid treatment for pregnant women to protect baby brain development.
What could go wrong
This is a small, completed sub-study (71 infants) that only observes development, not a treatment trial. Results may not apply to all babies or show clear differences between the two drug forms.

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.

Participants

71 people

The number who actually took part.

Started

Jun 2021

Finished

Dec 2024

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.

Who is studied

Participants in this study were recruited from the main CTN-0080 MOMs (NCT03918850) study sample.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

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: * The participant must be the caretaker of an infant that was delivered as part of the MOMs trial (Unique protocol ID: 2019-0429-1). Exclusion Criteria: \-

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Conditions

The condition(s) this trial relates to.

drug dependence neonatal abstinence syndrome opiate dependence pregnancy disorder substance abuse substance-related disorder

As listed by the trial registrant

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

Drug abuse Drug abuse in pregnancy Drug addiction Neonatal abstinence syndrome Neonatal opiate withdrawal syndrome Opioid-related disorders Pregnancy related Substance abuse

Contacts and locations

Locations

  • Addiction Recovery Services (ARS), Swedish Medical Center

    Seattle, Washington, 98107, United States

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

  • CODA, Inc.

    Portland, Oregon, 97214, United States

  • Gateway Community Services

    Jacksonville, Florida, 32204, United States

  • Marshall Health MARC Program

    Huntington, West Virginia, 25701, United States

  • Massachusetts General Hospital HOPE Clinic

    Boston, Massachusetts, 02114, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Pregnancy Recovery Center at Magee-Womens Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Utah SUPeRAD Clinic

    Salt Lake City, Utah, 84108, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

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