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Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study

NCT03911466 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 97

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). Participants in MOMs will be offered the opportunity to enroll in this sub-study, which is designed to evaluate conceptual models of the mechanisms by which extended-release buprenorphine (BUP-XR), may improve mother-infant outcomes, compared to sublingual buprenorphine (BUP-SL). The additional data collected in this sub-study will be combined with data from the main MOMs trial.

It is hypothesized that: (1) the buprenorphine blood levels will vary, depending on which formulation of buprenorphine was received, (2) the variation in buprenorphine blood levels will be associated with fetal behavior (including fetal heart rate variability) (3) the variation in buprenorphine blood levels will be associated with differences in mother outcomes (including medication adherence and illicit opioid use) (4) the variation in buprenorphine blood levels and in fetal behavior will be associated with infant outcomes (including neonatal opioid withdrawal syndrome and infant development).

Conditions

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

Interventions

DRUG

Buprenorphine Injection

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

DRUG

Buprenorphine Sublingual Product

Sublingual buprenorphine (BUP-SL), administered daily.

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

Min Age
18 Years
Max Age
41 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-21
Primary Completion
2024-11-06
Completion
2024-11-06
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 NCT03911466 on ClinicalTrials.gov