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

Completed

Conditions studied: Opioid-Related Disorders, Drug Addiction, Pregnancy Related, Substance Abuse, Drug Abuse, Neonatal Abstinence Syndrome, Neonatal Opiate Withdrawal Syndrome, Drug Abuse in Pregnancy

In brief

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.

Key facts

Study ID

NCT03911739

Run by

T. John Winhusen, PhD

People needed

71

Starts

2021-06-14

Expected to finish

2024-12-30

Last updated by the study team

2026-03-16

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

Where it is running

• Gateway Community Services — Jacksonville, Florida, United States
• Massachusetts General Hospital HOPE Clinic — Boston, Massachusetts, United States
• Boston Medical Center — Boston, Massachusetts, United States
• CODA, Inc. — Portland, Oregon, United States
• Pregnancy Recovery Center at Magee-Womens Hospital of UPMC — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Utah SUPeRAD Clinic — Salt Lake City, Utah, United States
• Addiction Recovery Services (ARS), Swedish Medical Center — Seattle, Washington, United States
• Marshall Health MARC Program — Huntington, West Virginia, United States

Full record on ClinicalTrials.gov

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