MOMs: Medication Treatment for Opioid Use Disorder in Expectant Mothers

Sponsor
T. John Winhusen, PhD (Other)
Overall Status
Recruiting
CT.gov ID
NCT03918850
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

The primary objective of this study is to evaluate the impact of treating opioid use disorder (OUD) in pregnant women with extended-release buprenorphine (BUP-XR), compared to sublingual buprenorphine (BUP-SL), on mother and infant outcomes. The primary hypothesis is that the BUP-XR group will not have greater illicit opioid use than the BUP-SL group during pregnancy (non-inferiority).

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

Detailed Description

This is an intent-to-treat, two-arm, open-label, pragmatic randomized controlled trial. Eligible participants will be randomized in a 1:1 ratio to BUP-XR or BUP-SL, balancing on site, estimated gestational age (EGA) at time of randomization (6 weeks-18 weeks vs. 19 weeks-30 weeks), and whether they are on BUP-SL at the time of randomization (yes vs. no). Participants will be provided with study medication and attend weekly medication visits through 12 months postpartum.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This is an intent-to-treat, two-arm, open-label, pragmatic randomized controlled trial.This is an intent-to-treat, two-arm, open-label, pragmatic randomized controlled trial.
Masking:
None (Open Label)
Masking Description:
The primary outcome is assessed in a masked fashion by a central laboratory, but there is no masking for other outcomes.
Primary Purpose:
Treatment
Official Title:
Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs): a Pragmatic Randomized Trial Comparing Extended-release and Daily Buprenorphine Formulations
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. Proportion of illicit opioid-negative urine samples during pregnancy [Screening through delivery]

      Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of illicit opioids and/or their metabolites.

    Secondary Outcome Measures

    1. Total days of neonatal opioid treatment during the hospital stay [Neonate discharge from hospital, typically within 1 month postpartum]

      This outcome will be abstracted from the medical record.

    2. Proportion of illicit opioid-negative urine samples postpartum [Delivery through 12 months postpartum]

      Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of illicit opioids and/or their metabolites.

    3. Proportion of days with study medication adherence [Screening through 12 months postpartum]

      Adherence to treatment during pregnancy through 12 months postpartum

    4. Proportion of drug and alcohol-negative urine samples [Screening through 12 months postpartum]

      Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of alcohol, illicit drugs and/or their metabolites.

    5. Opioid Craving Scale [Screening through delivery]

      The scale consists of 3 items, measuring craving, cue-induced craving, and likelihood of using, rated on a visual analogue scale from 0-10. The total is calculated by averaging the 3 item scores. Higher scores indicate greater levels of opioid craving.

    6. Opioid Craving Scale [Delivery through 12 months postpartum]

      The scale consists of 3 items, measuring craving, cue-induced craving, and likelihood of using, rated on a visual analogue scale from 0-10. The total is calculated by averaging the 3 item scores. Higher scores indicate greater levels of opioid craving.

    7. Adequacy of Prenatal Care Utilization Index [At delivery]

      The information will be derived from either medical records or the birth certificate.

    8. Short Opiate Withdrawal Scale (SOWS)-Gossop [Screening through 12 months postpartum]

      Measure of maternal opioid withdrawal symptoms.

    9. Opioid Medication for Neonatal Opioid Withdrawal Syndrome (NOWS) Symptoms [Neonate discharge from hospital, typically within 1 month postpartum]

      Use of opioid medication for NOWS symptoms will be abstracted from the medical record.

    10. Infant Hospital Length of Stay [Neonate discharge from hospital, typically within 1 month postpartum]

      Infant hospital length of stay (LOS) defined as the infant's age, in days, at discharge will be abstracted from the medical record. (Infant)

    11. Adjunct Medications [Neonate discharge from hospital, typically within 1 month postpartum]

      Use of adjunct medications (e.g., phenobarbital, clonidine) will be abstracted from the medical record.

    12. Neonatal Opioid Withdrawal Syndrome (NOWS) Peak Score [Neonate discharge from hospital, typically within 1 month postpartum]

      NOWS peak score will be abstracted from the medical record. Because sites may use different NOWS scoring systems, the scoring system that was used will be included as part of the peak score abstraction.

    13. Diagnosis code for Neonatal Opioid Withdrawal Syndrome (NOWS) [Neonate discharge from hospital, typically within 1 month postpartum]

      A diagnosis code indicative of NOWS (Yes/No) will be abstracted from the medical record.

    14. Custody at discharge [Neonate discharge from hospital, typically within 1 month postpartum]

      For example, whether the infant is discharged in custody of mother, other relative, foster/adoptive family, etc. This will be abstracted from the medical record.

    15. Medications at discharge [Neonate discharge from hospital, typically within 1 month postpartum]

      Medications that the infant is to continue receiving at discharge will be abstracted from the medical record.

    16. Child protective services open case [Neonate discharge from hospital, typically within 1 month postpartum]

      Whether or not there is an open child protective services at discharge (yes/no) will be abstracted from the medical record.

    17. Ages and Stages Questionnaire, third edition (ASQ-3) [6 months postpartum]

      To screen for developmental issues in the infant.

    18. Ages and Stages Questionnaire, third edition (ASQ-3) [12 months postpartum]

      To screen for developmental issues in the infant.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 41 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    Potential participants must:
    1. be 18-41 years of age

    2. be pregnant with an estimated gestational age (EGA) of 6 - 30 weeks at randomization, has evidence of a viable intrauterine pregnancy if EGA < 12 weeks and is not planning to terminate the pregnancy

    3. have a single fetus pregnancy (can be based on self-report if an objective assessment is unavailable)

    4. meet Diagnostic and Statistical Manual (DSM)-5 criteria for moderate/severe OUD and be a good candidate for BUP maintenance and/or be currently prescribed BUP for the treatment of OUD

    5. be willing to be randomized to BUP-XR or BUP-SL and to comply with study procedures, including weekly Medication Check Visits

    6. be planning to deliver at one of the hospitals for which the BORN survey was completed and that: a) has a written protocol for the management of neonatal abstinence syndrome (NAS) / neonatal withdrawal syndrome (NOWS), b) offers rooming-in while infants are being observed for NAS/NOWS; and c) does not send infants home on opioids for the treatment of NAS/NOWS

    7. be enrolled in outpatient addiction treatment at a participating site (e.g., have completed intake)

    8. be able to understand the study, and having understood, provide written informed consent in English

    Exclusion Criteria:
    Potential participants must not:
    1. have a physiological dependence on alcohol or sedatives requiring medical detoxification

    2. have a psychiatric condition that, in the judgment of the site medical clinician (MC), would make study participation unsafe or which would make treatment compliance difficult. Examples include:

    • Suicidal or homicidal ideation requiring immediate attention

    • Severe, inadequately-treated mental health disorder (e.g., active psychosis, uncontrolled bipolar disorder)

    1. have a medical condition that, in the judgment of the study MC, would make study participation unsafe or which would make treatment compliance difficult. Medical conditions that may compromise participant safety or study conduct include, but are not limited to, allergy/sensitivity to study medications and the following based on clinical labs:
    • aspartate aminotransferase (AST) / alanine aminotransferase (ALT) greater than 5X upper limit of normal

    • serum creatinine greater than 1.5X upper limit of normal

    • total bilirubin greater than 1.5X upper limit of normal

    1. be currently in jail, prison or any inpatient overnight facility as required by court of law or have pending legal action or other situation (e.g., unstable living arrangements) that, in the judgement of the site investigator, could prevent participation in the study or in any study activities;

    2. be currently receiving methadone or naltrexone for the treatment of OUD;

    3. be enrolled in or planning to enroll in treatment beyond the level 3.3 (Clinically Managed Population-Specific High-Intensity Residential Services) of the American Society of Addiction Medicine criteria; for level 3.3, the participant must have the ability to leave the facility unaccompanied by staff as needed;

    4. be enrolled in or planning to enroll in: a) a trial testing medication for managing OUD during pregnancy; b) research testing an intervention for substance use disorder or NOWS in their infant unless they are willing to provide a release for the research records.

    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:
    NCT03918850
    Other Study ID Numbers:
    • 2019-0429-1
    • UG1DA013732
    First Posted:
    Apr 18, 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