Medication Treatment for Opioid Use Disorder in Expectant Mothers: Infant Neurodevelopmental Outcomes Sub-study

NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs): Infant Neurodevelopmental Outcomes (INO) Sub-study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03911739

Acronym

MOMs-INO

Enrollment

Registered

2019-04-11

Start date

2021-06-14

Completion date

2024-12-30

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Abuse, Drug Abuse in Pregnancy, Drug Addiction, Neonatal Abstinence Syndrome, Neonatal Opiate Withdrawal Syndrome, Opioid-Related Disorders, Pregnancy Related, Substance Abuse

Keywords

CTN-0080, clinical trials network, medication assisted treatment, pharmacokinetics

Brief summary

This is a sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1). Caretakers of the infants delivered by MOMs participants will be offered the opportunity to enroll in this sub-study, which is designed to evaluate the impact of extended-release buprenorphine (BUP-XR), relative to sublingual buprenorphine (BUP-SL), on infant neurodevelopment. The additional data collected in this sub-study will be combined with data from the main MOMs trial.

Interventions

DRUGBuprenorphine Injection

Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).

DRUGBuprenorphine Sublingual Product

Sublingual buprenorphine (BUP-SL), administered daily.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Bayley Scales of Infant Development	24 months post-partum	The Bayley Scales of Infant Development is considered the gold standard assessment of early child development and includes cognitive, language, fine motor, and gross motor subscales. Subscale scores each range from 1 - 19, with higher scores indicating higher performance.

Secondary

Measure	Time frame	Description
Bayley Scales of Infant Development	12 months post-partum	The Bayley Scales of Infant Development is considered the gold standard assessment of early child development and includes cognitive, language, fine motor, and gross motor subscales. Subscale scores each range from 1 - 19, with higher scores indicating higher performance.
Child Behavior Checklist	24 months post-partum	The Child Behavior Checklist includes items that describe behavioral, emotional, and social problems that characterize preschool children.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORT. John Winhusen, PhD

University of Cincinnati

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026