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Medication Treatment for Opioid Use Disorder in Expectant Mothers: Infant Neurodevelopmental Outcomes Sub-study (MOMs-INO)

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ClinicalTrials.gov Identifier: NCT03911739
Recruitment Status : Not yet recruiting
First Posted : April 11, 2019
Last Update Posted : April 12, 2019
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
The Emmes Company, LLC
Information provided by (Responsible Party):
Theresa Winhusen, PhD, University of Cincinnati

Tracking Information
First Submitted Date  ICMJE April 9, 2019
First Posted Date  ICMJE April 11, 2019
Last Update Posted Date April 12, 2019
Estimated Study Start Date  ICMJE October 2020
Estimated Primary Completion Date January 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2019)
Bayley Scales of Infant Development [ Time Frame: 24 months post-partum ]
The Bayley Scales of Infant Development is considered the gold standard assessment of early child development and includes cognitive, language, fine motor, and gross motor subscales. Subscale scores each range from 1 - 19, with higher scores indicating higher performance.
Original Primary Outcome Measures  ICMJE
 (submitted: April 9, 2019)
Bayley Scales of Infant Development [ Time Frame: 24 months post-partum ]
The Bayley Scales of Infant Development is considered the gold standard assessment of early child development and includes cognitive, language, fine motor, and gross motor subscales.
Change History Complete list of historical versions of study NCT03911739 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2019)
  • Bayley Scales of Infant Development [ Time Frame: 12 months post-partum ]
    The Bayley Scales of Infant Development is considered the gold standard assessment of early child development and includes cognitive, language, fine motor, and gross motor subscales. Subscale scores each range from 1 - 19, with higher scores indicating higher performance.
  • Child Behavior Checklist [ Time Frame: 24 months post-partum ]
    The Child Behavior Checklist includes items that describe behavioral, emotional, and social problems that characterize preschool children.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2019)
  • Bayley Scales of Infant Development [ Time Frame: 12 months post-partum ]
    The Bayley Scales of Infant Development is considered the gold standard assessment of early child development and includes cognitive, language, fine motor, and gross motor subscales.
  • Child Behavior Checklist [ Time Frame: 24 months post-partum ]
    The Child Behavior Checklist includes items that describe behavioral, emotional, and social problems that characterize preschool children.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Medication Treatment for Opioid Use Disorder in Expectant Mothers: Infant Neurodevelopmental Outcomes Sub-study
Official Title  ICMJE NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs): Infant Neurodevelopmental Outcomes (INO) Sub-study
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). Caretakers of the infants delivered by MOMs participants will be offered the opportunity to enroll in this sub-study, which is designed to evaluate the impact of extended-release buprenorphine (BUP-XR), relative to sublingual buprenorphine (BUP-SL), on infant neurodevelopment. The additional data collected in this sub-study will be combined with data from the main MOMs trial.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Opioid-Related Disorders
  • Drug Addiction
  • Pregnancy Related
  • Substance Abuse
  • Drug Abuse
  • Neonatal Abstinence Syndrome
  • Neonatal Opiate Withdrawal Syndrome
  • Drug Abuse in Pregnancy
Intervention  ICMJE
  • Drug: Buprenorphine Injection
    Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
    Other Name: CAM2038
  • Drug: Buprenorphine Sublingual Product
    Sublingual buprenorphine (BUP-SL), administered daily.
    Other Names:
    • Subutex
    • Suboxone
Study Arms  ICMJE
  • 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.).

    Intervention: Drug: Buprenorphine Injection
  • 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.).

    Intervention: Drug: Buprenorphine Sublingual Product
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 9, 2019)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2024
Estimated Primary Completion Date January 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The participant must be the caretaker of an infant that was delivered as part of the MOMs trial (Unique protocol ID: 2019-0429-1).

Exclusion Criteria:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Frankie Kropp, MS 513-585-8290 kroppfb@ucmail.uc.edu
Contact: Ben Kropp, MSLS 513-585-8287 kroppbn@ucmail.uc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03911739
Other Study ID Numbers  ICMJE 2019-0429-3
UG1DA013732 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Responsible Party Theresa Winhusen, PhD, University of Cincinnati
Study Sponsor  ICMJE Theresa Winhusen, PhD
Collaborators  ICMJE
  • National Institute on Drug Abuse (NIDA)
  • The Emmes Company, LLC
Investigators  ICMJE
Principal Investigator: Theresa Winhusen, PhD University of Cincinnati
PRS Account University of Cincinnati
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP