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NCT Number: NCT03911739

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

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.

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Key information

Conditions

Opioid-related Disorders Chemically-Induced Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Drug Abuse Drug Abuse in Pregnancy Drug Addiction Infant, Newborn, Diseases Mental Disorders Narcotic-Related Disorders Neonatal Abstinence Syndrome Neonatal Opiate Withdrawal Syndrome Pregnancy Related Substance Abuse Substance-Related Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

Gateway Community Services, Jacksonville, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Buprenorphine Injection

Drug

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

Other names: CAM2038

Buprenorphine Sublingual Product

Drug

Sublingual buprenorphine (BUP-SL), administered daily.

Other names: Subutex, Suboxone

Primary outcomes

  1. Bayley Scales of Infant Development

    Time frame: 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 outcomes

  1. Bayley Scales of Infant Development

    Time frame: 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.

  2. Child Behavior Checklist

    Time frame: 24 months post-partum

    The Child Behavior Checklist includes items that describe behavioral, emotional, and social problems that characterize preschool children.

Sponsors and collaborators

Lead sponsor

T. John Winhusen, PhD

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • The Emmes Company, LLC

Registry information

Official study title

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

Acronym: MOMs-INO

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 11, 2019
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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