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Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs)

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ClinicalTrials.gov Identifier: NCT03918850
Recruitment Status : Not yet recruiting
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
The Emmes Company, LLC
Information provided by (Responsible Party):
Theresa Winhusen, PhD, University of Cincinnati

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. Proportion of days with study medication adherence [ Time Frame: Screening through 12 months postpartum ]
    Adherence to treatment during pregnancy through 12 months postpartum

  4. 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.

  5. 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.

  6. 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.

  7. Adequacy of Prenatal Care Utilization Index [ Time Frame: At delivery ]
    The information will be derived from either medical records or the birth certificate.

  8. Short Opiate Withdrawal Scale (SOWS)-Gossop [ Time Frame: Screening through 12 months postpartum ]
    Measure of maternal opioid withdrawal symptoms.

  9. 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.

  10. 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)

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. Ages and Stages Questionnaire, third edition (ASQ-3) [ Time Frame: 6 months postpartum ]
    To screen for developmental issues in the infant.

  18. Ages and Stages Questionnaire, third edition (ASQ-3) [ Time Frame: 12 months postpartum ]
    To screen for developmental issues in the infant.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 41 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03918850


Contacts
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Contact: Frankie Kropp, MS 513-585-8290 kroppfb@ucmail.uc.edu
Contact: Ben Kropp, MSLS 513-585-8287 kroppbn@ucmail.uc.edu

Locations
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United States, California
Zuckerberg San Francisco General
San Francisco, California, United States, 94110
United States, Florida
Gateway Community Services
Jacksonville, Florida, United States, 32204
United States, Kentucky
University of Kentucky Center on Drug and Alcohol Research (CDAR)
Lexington, Kentucky, United States, 40502
United States, Massachusetts
Massachusetts General Hospital HOPE Clinic
Boston, Massachusetts, United States, 02114
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, New Mexico
University of New Mexico Milagro Clinic
Albuquerque, New Mexico, United States, 87106
United States, Oregon
CODA, Inc.
Portland, Oregon, United States, 97214
United States, Pennsylvania
Pregnancy Recovery Center at Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Utah
University of Utah SUPeRAD Clinic
Salt Lake City, Utah, United States, 84108
United States, Washington
Addiction Recovery Services (ARS), Swedish Medical Center
Seattle, Washington, United States, 98107
Sponsors and Collaborators
Theresa Winhusen, PhD
National Institute on Drug Abuse (NIDA)
The Emmes Company, LLC
Investigators
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Principal Investigator: Theresa Winhusen, PhD University of Cincinnati

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Responsible Party: Theresa Winhusen, PhD, Professor; Vice Chair and Division Director of Addiction Sciences, University of Cincinnati
ClinicalTrials.gov Identifier: NCT03918850     History of Changes
Other Study ID Numbers: 2019-0429-1
UG1DA013732 ( U.S. NIH Grant/Contract )
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
URL: https://datashare.nida.nih.gov/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Theresa Winhusen, PhD, University of Cincinnati:
CTN-0080
clinical trials network
medication assisted treatment

Additional relevant MeSH terms:
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Disease
Syndrome
Substance-Related Disorders
Opioid-Related Disorders
Neonatal Abstinence Syndrome
Substance Withdrawal Syndrome
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders
Infant, Newborn, Diseases
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists