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

Pregnancy Related Clinical Trial

— MOMs-INO  

Official title:

NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs): Infant Neurodevelopmental Outcomes (INO) Sub-study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03911739
• Other study ID #: 2019-0429-3
• Secondary ID: UG1DA013732
• Status: Recruiting
• Phase: Phase 3
• Start date: June 14, 2021
• Est. completion date: January 31, 2025

Study information

• Verified date: September 2023
• Source: University of Cincinnati
• Contact: Frankie Kropp, MS
• Phone: 513-585-8290
• Email: kroppfb[@]ucmail.uc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

-

Related Conditions & MeSH terms

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

Intervention

Drug:
• Buprenorphine Injection
Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
• Buprenorphine Sublingual Product
Sublingual buprenorphine (BUP-SL), administered daily.

Locations

Country	Name	City	State
United States	University of New Mexico Milagro Clinic	Albuquerque	New Mexico
United States	Boston Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital HOPE Clinic	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Cincinnati Health Perinatal Addictions Program	Cincinnati	Ohio
United States	Marshall Health MARC Program	Huntington	West Virginia
United States	Gateway Community Services	Jacksonville	Florida
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Pregnancy Recovery Center at Magee-Womens Hospital of UPMC	Pittsburgh	Pennsylvania
United States	CODA, Inc.	Portland	Oregon
United States	University of Utah SUPeRAD Clinic	Salt Lake City	Utah
United States	Zuckerberg San Francisco General	San Francisco	California
United States	Addiction Recovery Services (ARS), Swedish Medical Center	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
T. John Winhusen, PhD	National Institute on Drug Abuse (NIDA), The Emmes Company, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 months post-partum
Secondary	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.	12 months post-partum
Secondary	Child Behavior Checklist	The Child Behavior Checklist includes items that describe behavioral, emotional, and social problems that characterize preschool children.	24 months post-partum