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MRI scans reveal hidden effects of opioids on unborn babies

NCT ID NCT06415994

Knowledge-focused Sponsor: Senthil Sadhasivam 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This observational study follows pregnant women with opioid use disorder who are taking buprenorphine or methadone. Researchers use MRI scans of the placenta and fetal brain during the second and third trimesters, along with blood samples and developmental assessments after birth, to understand how prenatal opioid exposure affects the baby. The goal is to identify biomarkers that could lead to safer treatments and better outcomes for both mother and child.

What this could mean

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

What this could lead to
If successful, this research could point toward ways to reduce neonatal opioid withdrawal syndrome and improve long-term outcomes for children exposed to opioids before birth.
What could go wrong
This is an observational study, not a treatment trial, so it cannot directly change outcomes. Results may not apply to all populations or opioid treatments.

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

About 250 people

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

Started

Feb 2024

Expected to finish

Dec 2029

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.

Who is studied

Any woman of the age of 18 or older that is having a single pregnancy, and currently taking buprenorphine or methadone for opioid use disorder.

Ages

18 to 100 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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.

Pregnant women with opioid use disorder Inclusion Criteria: * Age \>18 years * Currently taking buprenorphine or methadone for OUD and are enrolled in a prenatal opioid maintenance program * Singleton Pregnancy * Planned delivery at Indiana University or University of Pittsburgh study sites Exclusion Criteria: * Serious maternal medical illness as deemed by study physician investigators that would make it challenging to comply with study procedures * Known or suspected major fetal/ neonatal congenital abnormalities * HIV or AIDS Infants with prenatal opioid exposure: Inclusion: 1. Prenatal buprenorphine or methadone exposure 2. Born to mother enrolled in Opioid Use Disorder arm of study Exclusion: Major congenital anomalies or genetic syndromes affecting neurodevelopment Control Pregnant Women: Inclusion: 1. Women \>18 Years of age 2. Healthy singleton pregnancy 3. Planned delivery at Indiana University or University of Pittsburgh study sites Exclusion: 1. Serious maternal medical illness as deemed by study physician investigators that would make it challenging to comply with study procedures 2. HIV or AIDS 3. Known or suspected major fetal congenital abnormalities 4. Any history of opioid misuse before or during pregnancy-per self-report and clinical notes. Control infants: Inclusion: Born to control pregnant mother enrolled in study Exclusion: Any major congenital anomalies, genetic abnormalities, neurologic abnormalities, syndromes, or chronic medical conditions affecting neurodevelopment.

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Conditions

The condition(s) this trial relates to.

Narcotic-Related Disorders opiate dependence pregnancy disorder substance-related disorder

As listed by the trial registrant

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

Buprenorphine dependence Methadone dependence Narcotic-related disorders Opioid-use disorder Pregnancy related Substance-related disorders

How to take part

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

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202, United States

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15260, United States

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