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Observational Study of Opioid Use Disorder in Pregnancy

This observational study is looking at how buprenorphine (also known as Subutex), a medication used to treat opioid use disorder, affects pregnant mothers and their babies. Researchers want to understand how clinical and genetic factors might predict how well mothers respond to treatment and if babies are at risk for neonatal abstinence syndrome (NAS), which is when a baby experiences withdrawal symptoms after birth. You could join if you are pregnant, at least 18 years old, and are currently taking buprenorphine for opioid use disorder through a prenatal program at IU Health University Hospital. The study will follow mothers and babies for up to 5 years to see the long-term effects of buprenorphine on opioid misuse severity and the need for NAS treatment.

Study design
This is an observational study planning to enroll 600 participants, including 200 mothers with opioid use disorder and 100 mothers without previous opioid use.
What's involved
Participants will have fetal and neonatal MRIs, and blood will be collected throughout pregnancy for DNA, genetic, and pharmacokinetic (how the body handles the drug) samples. Babies will have follow-up with another neonatal MRI, blood draws, and infant/child assessments for up to 2 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years after the baby is born to assess opioid misuse severity and the need for NAS treatment.

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NCT03923374

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

Recruiting
Not specifiedAges 18+Observational
Senthil Sadhasivam
~600 participants
Updated 2025-12-18 on ClinicalTrials.gov
What's tested:Subutex / BuprenorphineFetal & Neonatal MRIDNA/Genetic/Pharmacokenetic Blood Draws

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of opioid misuse severity using assessments
Measured over 5 years
+1 more outcome measured

Conditions

Opioid-use Disorder
Opioid Use, Unspecified
Buprenorphine Dependence

Explore related trials

Opioid Use Disorder

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Senthil Sadhasivam, MD, MPH · PRINCIPAL_INVESTIGATOR · University of Pittsburgh, UPMC

Who to contact

Senthil Sadhasivam, MD, MPH
[email protected]
4126474484
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Eligibility criteria

Inclusion

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

Serious maternal medical illness as deemed by study physician or investigator.
Known or suspected major fetal/neonatal congenital abnormalities.

What this trial measures

  • Incidence of opioid misuse severity using assessments5 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 syndrome5 years

    Incidence of Neonatal Abstinence Syndrome and need for pharmacological treatment.