Medication Treatment for Opioid Use Disorder in Expectant Mothers

Overview

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).

Full Title of Study: “Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs): a Pragmatic Randomized Trial Comparing Extended-release and Daily Buprenorphine Formulations”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2025

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.

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.

Arms, Groups and Cohorts

  • 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.).
  • 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.).

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of illicit opioid-negative urine samples during pregnancy
    • Time Frame: 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 Measures

  • Total days of neonatal opioid treatment during the hospital stay
    • Time Frame: Neonate discharge from hospital, typically within 1 month postpartum
    • This outcome will be abstracted from the medical record.
  • Proportion of illicit opioid-negative urine samples postpartum
    • Time Frame: 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.
  • Proportion of days with study medication adherence
    • Time Frame: Screening through 12 months postpartum
    • Adherence to treatment during pregnancy through 12 months postpartum
  • Proportion of drug and alcohol-negative urine samples
    • Time Frame: 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.
  • Opioid Craving Scale
    • Time Frame: 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.
  • Opioid Craving Scale
    • Time Frame: 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.
  • Adequacy of Prenatal Care Utilization Index
    • Time Frame: At delivery
    • The information will be derived from either medical records or the birth certificate.
  • Short Opiate Withdrawal Scale (SOWS)-Gossop
    • Time Frame: Screening through 12 months postpartum
    • Measure of maternal opioid withdrawal symptoms.
  • Opioid Medication for Neonatal Opioid Withdrawal Syndrome (NOWS) Symptoms
    • Time Frame: Neonate discharge from hospital, typically within 1 month postpartum
    • Use of opioid medication for NOWS symptoms will be abstracted from the medical record.
  • Infant Hospital Length of Stay
    • Time Frame: 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)
  • Adjunct Medications
    • Time Frame: Neonate discharge from hospital, typically within 1 month postpartum
    • Use of adjunct medications (e.g., phenobarbital, clonidine) will be abstracted from the medical record.
  • Neonatal Opioid Withdrawal Syndrome (NOWS) Peak Score
    • Time Frame: 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.
  • Diagnosis code for Neonatal Opioid Withdrawal Syndrome (NOWS)
    • Time Frame: Neonate discharge from hospital, typically within 1 month postpartum
    • A diagnosis code indicative of NOWS (Yes/No) will be abstracted from the medical record.
  • Custody at discharge
    • Time Frame: 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.
  • Medications at discharge
    • Time Frame: 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.
  • Child protective services open case
    • Time Frame: 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.
  • Ages and Stages Questionnaire, third edition (ASQ-3)
    • Time Frame: 6 months postpartum
    • To screen for developmental issues in the infant.
  • Ages and Stages Questionnaire, third edition (ASQ-3)
    • Time Frame: 12 months postpartum
    • To screen for developmental issues in the infant.

Participating in This Clinical Trial

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) 3. 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 4. 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; 5. be currently receiving methadone or naltrexone for the treatment of OUD; 6. be enrolled in or planning to enroll in treatment beyond the level of 3.1 (clinically managed low-intensity residential services) of the American Society of Addiction Medicine criteria 7. 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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 41 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Theresa Winhusen, PhD
  • Collaborator
    • National Institute on Drug Abuse (NIDA)
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Theresa Winhusen, PhD, Professor; Vice Chair and Division Director of Addiction Sciences – University of Cincinnati
  • Overall Official(s)
    • Theresa Winhusen, PhD, Principal Investigator, University of Cincinnati
  • Overall Contact(s)
    • Frankie Kropp, MS, 513-585-8290, kroppfb@ucmail.uc.edu

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