Multimodal Fetal and Placental Imaging and Biomarkers of Clinical Outcomes in Opioid Use Disorder

Enrolling by invitationOBSERVATIONAL
Enrollment

250

Participants

Timeline

Start Date

February 13, 2024

Primary Completion Date

December 1, 2028

Study Completion Date

December 1, 2029

Conditions
Opioid Use DisorderSubstance-Related DisordersPregnancy RelatedNarcotic-Related DisordersBuprenorphine DependenceMethadone Dependence
Interventions
DRUG

Buprenorphine or Methadone Treatment

Pregnant mothers must be taking Buprenorphine or Methadone

DIAGNOSTIC_TEST

Fetal and Placental MRI

"Two MRIs :~* Second Trimester~* Third Trimester"

BEHAVIORAL

Child Developmental Assessment

At 1 year of life child will receive a developmental assessment

BEHAVIORAL

Questionnaires

Participants will answer questionnaires on their medical history, pregnancy, substance use, and after birth: their child's development

OTHER

Blood and Placental Samples

"At each MRI visit a blood sample will be collected for substances, DNA, RNA, epigenetics, and placental biomarkers.~At delivery: A sample of placenta will be collected for RNA, DNA, and epigenetic analysis."

Trial Locations (2)

15260

University of Pittsburg, Pittsburgh

46202

Riley Hospital for Children, Indianapolis

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

Indiana University

OTHER