An observational study in Opioid-use Disorder, Opioid Use, Unspecified and Buprenorphine Dependence, sponsored by Senthil Sadhasivam. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-18.
Sponsored by Senthil Sadhasivam · Observational
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).
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.
Any woman of the age of 18 or older that is having a single pregnancy, and currently taking buprenorphine for opioid use disorder.
Exclusion Criteria:
Planned recruitment of 200 pregnant (\<16weeks) mothers who have opioid use disorder and are taking buprenorphine
Drug: Subutex / Buprenorphine · Diagnostic Test: Fetal & Neonatal MRI · Diagnostic Test: DNA/Genetic/Pharmacokenetic Blood Draws
Planned recruitment of 100 pregnant (\>16weeks) mothers who do not have any history of opioid use disorder.
Diagnostic Test: Fetal & Neonatal MRI · Diagnostic Test: DNA/Genetic/Pharmacokenetic Blood Draws
Pregnant Mothers must be taking buprenorphine / subutex for opioid use disorder.
Mothers who consent will be given a fetal MRI and after the baby is born, a neonatal MRI.
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.
Incidence of opioid misuse severity using assessments
Incidence of opioid misuse severity and buprenorphine treatment response will be assessed by the treating physician using assessments such as Who Assist, TCU Motform, Adverse Childhood Experience Assessment, Ham-A and Ham-D.
Time frame: 5 years
Pharmacological treatment for neonatal abstinence syndrome
Incidence of Neonatal Abstinence Syndrome and need for pharmacological treatment.
Time frame: 5 years
Incidence of adverse effects of buprenorphine using MRI
Incidence of adverse effects of buprenorphine use on fetal and placental changes using MRI.
Time frame: 5 years
Concentration of long-term neurodevelopmental outcomes using assessments
Concentration of long-term neurodevelopmental outcomes in neonates using the Ages and Stages Questionnaire and the Baileys follow-up assessment.
Time frame: 5 years
Plan to share: Undecided
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Senthil Sadhasivam