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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

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.

Condition or disease Intervention/treatment Phase
Opioid-Related Disorders Drug Addiction Pregnancy Related Substance Abuse Drug Abuse Neonatal Abstinence Syndrome Neonatal Opiate Withdrawal Syndrome Drug Abuse in Pregnancy Drug: Buprenorphine Injection Drug: Buprenorphine Sublingual Product Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 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): Infant Neurodevelopmental Outcomes (INO) Sub-study
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : January 2024
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. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

-


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): NCT03911739


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: NCT03911739     History of Changes
Other Study ID Numbers: 2019-0429-3
UG1DA013732 ( U.S. NIH Grant/Contract )
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: April 12, 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

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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
pharmacokinetics

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