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Clinical Trial Summary

The objective of this study is to better understand the comprehensive integration of both clinical and genetic factors that will help to identify mothers who could be at an increased risk of poor response to opioid substitution and infants at risk of significant neonatal abstinence syndrome (NAS).


Clinical Trial Description

One of the greatest impacts on maternal/infant health in the United States today is mother's who have opioid use disorder also known as OUD. This study will look at how in-utero buprenorphine also known as subutex, effects both mother/fetus in prenatal stages with MRI's, blood draws, and a series of assessments. After the neonate is born, there will be follow-up with that baby for up to 2 years with another neonatal MRI, blood draws and infant/child assessments. Planning to enroll 200 mothers who have opioid use disorder and 100 mothers with no previous opioid use. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03923374
Study type Observational [Patient Registry]
Source University of Pittsburgh
Contact Senthil Sadhasivam, MD, MPH
Phone 4126474484
Email sadhasivams@upmc.edu
Status Recruiting
Phase
Start date September 15, 2018
Completion date December 30, 2025

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