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

NCT03911739 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 71

Last updated 2026-03-16

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Buprenorphine Sublingual Product

Sublingual buprenorphine (BUP-SL), administered daily.

DRUG

Buprenorphine Injection

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

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • The Emmes Company, LLC

    collaborator INDUSTRY

  • T. John Winhusen, PhD

    lead OTHER

Principal Investigators

  • T. John Winhusen, PhD · University of Cincinnati

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-14
Primary Completion
2024-12-30
Completion
2024-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03911739 on ClinicalTrials.gov