Back to resultsMedication Treatment for Opioid Use Disorder in Expectant Mothers: Infant Neurodevelopmental Outcomes Sub-study (MOMs-INO)
Primary Purpose
Opioid-Related Disorders, Drug Addiction, Pregnancy Related
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine Injection
Buprenorphine Sublingual Product
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-Related Disorders focused on measuring CTN-0080, clinical trials network, medication assisted treatment, pharmacokinetics
Eligibility 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:
-
Sites / Locations
- Zuckerberg San Francisco General
- Gateway Community ServicesRecruiting
- Massachusetts General Hospital HOPE ClinicRecruiting
- Boston Medical CenterRecruiting
- University of New Mexico Milagro Clinic
- University of Cincinnati Health Perinatal Addictions Program
- CODA, Inc.
- Pregnancy Recovery Center at Magee-Womens Hospital of UPMCRecruiting
- Medical University of South CarolinaRecruiting
- Vanderbilt University Medical CenterRecruiting
- University of Utah SUPeRAD ClinicRecruiting
- Addiction Recovery Services (ARS), Swedish Medical Center
- Marshall Health MARC ProgramRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
BUP-XR
BUP-SL
Arm Description
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.).
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.).
Outcomes
Primary Outcome Measures
Bayley Scales of Infant Development
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
Bayley Scales of Infant Development
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
The Child Behavior Checklist includes items that describe behavioral, emotional, and social problems that characterize preschool children.
Full Information
NCT ID
NCT03911739
First Posted
April 9, 2019
Last Updated
September 25, 2023
Sponsor
T. John Winhusen, PhD
Collaborators
National Institute on Drug Abuse (NIDA), The Emmes Company, LLC
1. Study Identification
Unique Protocol Identification Number
NCT03911739
Brief Title
Medication Treatment for Opioid Use Disorder in Expectant Mothers: Infant Neurodevelopmental Outcomes Sub-study
Acronym
MOMs-INO
Official Title
NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs): Infant Neurodevelopmental Outcomes (INO) Sub-study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2021 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
T. John Winhusen, PhD
Collaborators
National Institute on Drug Abuse (NIDA), The Emmes Company, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders, Drug Addiction, Pregnancy Related, Substance Abuse, Drug Abuse, Neonatal Abstinence Syndrome, Neonatal Opiate Withdrawal Syndrome, Drug Abuse in Pregnancy
Keywords
CTN-0080, clinical trials network, medication assisted treatment, pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BUP-XR
Arm Type
Experimental
Arm Description
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.).
Arm Title
BUP-SL
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Buprenorphine Injection
Other Intervention Name(s)
CAM2038
Intervention Description
Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
Intervention Type
Drug
Intervention Name(s)
Buprenorphine Sublingual Product
Other Intervention Name(s)
Subutex, Suboxone
Intervention Description
Sublingual buprenorphine (BUP-SL), administered daily.
Primary Outcome Measure Information:
Title
Bayley Scales of Infant Development
Description
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.
Time Frame
24 months post-partum
Secondary Outcome Measure Information:
Title
Bayley Scales of Infant Development
Description
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.
Time Frame
12 months post-partum
Title
Child Behavior Checklist
Description
The Child Behavior Checklist includes items that describe behavioral, emotional, and social problems that characterize preschool children.
Time Frame
24 months post-partum
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frankie Kropp, MS
Phone
513-585-8290
Email
kroppfb@ucmail.uc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ben Kropp, MSLS
Phone
513-585-8287
Email
kroppbn@ucmail.uc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
T. John Winhusen, PhD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zuckerberg San Francisco General
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Individual Site Status
Withdrawn
Facility Name
Gateway Community Services
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Individual Site Status
Recruiting
Facility Name
Massachusetts General Hospital HOPE Clinic
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Name
University of New Mexico Milagro Clinic
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Cincinnati Health Perinatal Addictions Program
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Withdrawn
Facility Name
CODA, Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97214
Country
United States
Individual Site Status
Completed
Facility Name
Pregnancy Recovery Center at Magee-Womens Hospital of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Utah SUPeRAD Clinic
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Individual Site Status
Recruiting
Facility Name
Addiction Recovery Services (ARS), Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98107
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Marshall Health MARC Program
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Medication Treatment for Opioid Use Disorder in Expectant Mothers: Infant Neurodevelopmental Outcomes Sub-study
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