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

NCT ID NCT03911739

Completed Knowledge-focused Sponsor: T. John Winhusen, PhD Source: ClinicalTrials.gov ↗

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for DRUG ABUSE are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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

More trials for these conditions

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