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

March 11, 2026 updated by: T. John Winhusen, PhD

NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs): a Pragmatic Randomized Trial Comparing Extended-release and Daily Buprenorphine Formulations: Conceptual Model Assessments (CMA) 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). 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

97

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32204
        • Gateway Community Services
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital HOPE Clinic
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • University of New Mexico Milagro Clinic
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • University of Cincinnati Health Perinatal Addictions Program
    • Oregon
      • Portland, Oregon, United States, 97214
        • CODA, Inc.
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Pregnancy Recovery Center at Magee-Womens Hospital of UPMC
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University of Utah SUPeRAD Clinic
    • Washington
      • Seattle, Washington, United States, 98107
        • Addiction Recovery Services (ARS), Swedish Medical Center
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • Marshall Health MARC Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 37 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants in this study were recruited from the main CTN-0080 MOMs (NCT03918850) study sample.

Description

Inclusion Criteria:

  • Participating in the MOMs trial (Unique protocol ID: 2019-0429-1)

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
BUP-XR

Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly.

The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Drug: Buprenorphine Injection
Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
Other Names:
  • CAM2038
BUP-SL

Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase.

The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Drug: Buprenorphine Sublingual Product
Sublingual buprenorphine (BUP-SL), administered daily.
Other Names:
  • Subutex
  • Suboxone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmin of buprenorphine and metabolites in plasma
Time Frame: 2 weeks post-randomization
A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate adequacy of dose for the conceptual model.
2 weeks post-randomization
Cmin of buprenorphine and metabolites in plasma
Time Frame: 4 weeks post-randomization
A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate adequacy of dose for the conceptual model.
4 weeks post-randomization
Fetal heart rate variability
Time Frame: Estimated gestational age (EGA) approximately 36 weeks
This is the measure of primary interest from the fetal evaluation (non-stress test and biophysical profile).
Estimated gestational age (EGA) approximately 36 weeks
Cmin of buprenorphine and metabolites in plasma
Time Frame: Estimated gestational age (EGA) approximately 36 weeks
A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate trough-to-peak fluctuation for the conceptual model.
Estimated gestational age (EGA) approximately 36 weeks
Cmax of buprenorphine and metabolites in plasma
Time Frame: Estimated gestational age (EGA) approximately 36 weeks
A blood draw at the estimated time of maximum drug concentration ("peak") to evaluate trough-to-peak fluctuation for the conceptual model.
Estimated gestational age (EGA) approximately 36 weeks
Concentration of buprenorphine and metabolites in maternal plasma
Time Frame: Delivery
A blood draw around the time of delivery to evaluate the association between drug concentration and neonatal opioid withdrawal syndrome outcomes.
Delivery
Concentration of buprenorphine and metabolites in cord plasma
Time Frame: Delivery
Cord blood will be collected and used to estimate fetal exposure to buprenorphine.
Delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

T. John Winhusen, PhD

Collaborators

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

Investigators

  • Principal Investigator: T. John Winhusen, PhD, University of Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2020

Primary Completion (Actual)

November 6, 2024

Study Completion (Actual)

November 6, 2024

Study Registration Dates

First Submitted

April 9, 2019

First Submitted That Met QC Criteria

April 9, 2019

First Posted (Actual)

April 11, 2019

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-0429-2
  • UG1DA013732 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be transmitted by the study Data and Statistics Center to the designated party for de-identification, posting, storing, and archiving on NIDA's Data Share website. Data Share is an online repository of data from studies funded by the National Institute on Drug Abuse. All de-identified individual participant data is expected to be made available.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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