Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes

RecruitingOBSERVATIONAL
Enrollment

600

Participants

Timeline

Start Date

September 15, 2018

Primary Completion Date

December 30, 2025

Study Completion Date

December 30, 2026

Conditions
Opioid-use DisorderOpioid Use, UnspecifiedBuprenorphine Dependence
Interventions
DRUG

Subutex / Buprenorphine

Pregnant Mothers must be taking buprenorphine / subutex for opioid use disorder.

DIAGNOSTIC_TEST

Fetal & Neonatal MRI

Mothers who consent will be given a fetal MRI and after the baby is born, a neonatal MRI.

DIAGNOSTIC_TEST

DNA/Genetic/Pharmacokenetic Blood Draws

Throughout the pregnancy, Mothers will be participating in blood collection throughout the study. At enrollment, we will collect DNA, Genetic and PK blood specimens, then throughout the study, we will be collecting random PK samples.

Trial Locations (1)

15224

RECRUITING

UPMC Children's Hospital, Pittsburgh

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

Senthil Sadhasivam

OTHER