NCT03923374 · Senthil Sadhasivam
Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
(Mother/BabyOUD)
What this study is about
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).
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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).
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.
Primary outcome measures
Incidence of opioid misuse severity using assessments
Time frame: 5 years
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.
Pharmacological treatment for neonatal abstinence syndrome
Time frame: 5 years
Incidence of Neonatal Abstinence Syndrome and need for pharmacological treatment.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age greater 18 years
- Currently taking Buprenorphine for Opioid Use Disorder and enrolled in a prenatal opioid maintenance program in the antenatal clinic at IU Health University Hospital.
- Pregnant with single baby
- Planned delivery at Methodist, University or Riley Hospital
Exclusion criteria
- Serious maternal medical illness as deemed by study physician or investigator.
- Known or suspected major fetal/neonatal congenital abnormalities.
Where
- Pittsburgh, Pennsylvania
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 18, 2025 · Source of record for eligibility and locations