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

Sponsor
T. John Winhusen, PhD (Other)
Overall Status
Recruiting
CT.gov ID
NCT03911466
Collaborator
National Institute on Drug Abuse (NIDA) (NIH), The Emmes Company, LLC (Industry)
200
13
2
74.1
15.4
0.2

Study Details

Study Description

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). 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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Buprenorphine Injection
  • Drug: Buprenorphine Sublingual Product
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jul 21, 2020
Anticipated Primary Completion Date :
Sep 22, 2025
Anticipated Study Completion Date :
Sep 22, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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
  • Active Comparator: 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
  • Outcome Measures

    Primary Outcome Measures

    1. Cmin of buprenorphine and metabolites in plasma [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. Cmin of buprenorphine and metabolites in plasma [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.

    3. Fetal heart rate variability [Estimated gestational age (EGA) approximately 36 weeks]

      This is the measure of primary interest from the fetal evaluation (non-stress test and biophysical profile).

    4. Cmin of buprenorphine and metabolites in plasma [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.

    5. Cmax of buprenorphine and metabolites in plasma [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.

    6. Concentration of buprenorphine and metabolites in maternal plasma [Delivery]

      A blood draw around the time of delivery to evaluate the association between drug concentration and neonatal opioid withdrawal syndrome outcomes.

    7. Concentration of buprenorphine and metabolites in cord plasma [Delivery]

      Cord blood will be collected and used to estimate fetal exposure to buprenorphine.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 41 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Participating in the MOMs trial (Unique protocol ID: 2019-0429-1)
    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zuckerberg San Francisco General San Francisco California United States 94110
    2 Gateway Community Services Jacksonville Florida United States 32204
    3 Massachusetts General Hospital HOPE Clinic Boston Massachusetts United States 02114
    4 Boston Medical Center Boston Massachusetts United States 02118
    5 University of New Mexico Milagro Clinic Albuquerque New Mexico United States 87106
    6 University of Cincinnati Health Perinatal Addictions Program Cincinnati Ohio United States 45229
    7 CODA, Inc. Portland Oregon United States 97214
    8 Pregnancy Recovery Center at Magee-Womens Hospital of UPMC Pittsburgh Pennsylvania United States 15213
    9 Medical University of South Carolina Charleston South Carolina United States 29425
    10 Vanderbilt University Medical Center Nashville Tennessee United States 37232
    11 University of Utah SUPeRAD Clinic Salt Lake City Utah United States 84108
    12 Addiction Recovery Services (ARS), Swedish Medical Center Seattle Washington United States 98107
    13 Marshall Health MARC Program Huntington West Virginia United States 25701

    Sponsors and Collaborators

    • T. John Winhusen, PhD
    • National Institute on Drug Abuse (NIDA)
    • The Emmes Company, LLC

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    T. John Winhusen, PhD, Professor; Vice Chair and Division Director of Addiction Sciences, University of Cincinnati
    ClinicalTrials.gov Identifier:
    NCT03911466
    Other Study ID Numbers:
    • 2019-0429-2
    • UG1DA013732
    First Posted:
    Apr 11, 2019
    Last Update Posted:
    Feb 11, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by T. John Winhusen, PhD, Professor; Vice Chair and Division Director of Addiction Sciences, University of Cincinnati
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 11, 2022