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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03911739
Other study ID # 2019-0429-3
Secondary ID UG1DA013732
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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: -

Study Design


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
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