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

PHASE3CompletedINTERVENTIONAL
Enrollment

71

Participants

Timeline

Start Date

June 14, 2021

Primary Completion Date

December 30, 2024

Study Completion Date

December 30, 2024

Conditions
Opioid-Related DisordersDrug AddictionPregnancy RelatedSubstance AbuseDrug AbuseNeonatal Abstinence SyndromeNeonatal Opiate Withdrawal SyndromeDrug Abuse in Pregnancy
Interventions
DRUG

Buprenorphine Injection

Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).

DRUG

Buprenorphine Sublingual Product

Sublingual buprenorphine (BUP-SL), administered daily.

Trial Locations (10)

15213

Pregnancy Recovery Center at Magee-Womens Hospital of UPMC, Pittsburgh

25701

Marshall Health MARC Program, Huntington

29425

Medical University of South Carolina, Charleston

32204

Gateway Community Services, Jacksonville

37232

Vanderbilt University Medical Center, Nashville

84108

University of Utah SUPeRAD Clinic, Salt Lake City

97214

CODA, Inc., Portland

98107

Addiction Recovery Services (ARS), Swedish Medical Center, Seattle

02114

Massachusetts General Hospital HOPE Clinic, Boston

02118

Boston Medical Center, Boston

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

collaborator

The Emmes Company, LLC

INDUSTRY

lead

T. John Winhusen, PhD

OTHER