Recruiting

Observational Study

Sponsor:

Senthil Sadhasivam

Code:

NCT03923374

Conditions

Opioid-use Disorder

Opioid Use, Unspecified

Buprenorphine Dependence

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Subutex / Buprenorphine

Fetal & Neonatal MRI

DNA/Genetic/Pharmacokenetic Blood Draws

Study Details

Brief 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).

Conditions

Opioid-use Disorder

Opioid Use, Unspecified

Buprenorphine Dependence

Study ID

NCT03923374

Start date

Sep 15, 2018

Status verified date

Dec, 2025

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Arms

Pregnant Mothers with Opioid Use Disorder

Planned recruitment of 200 pregnant (<16weeks) mothers who have opioid use disorder and are taking buprenorphine

Pregnant Mothers

Planned recruitment of 100 pregnant (>16weeks) mothers who do not have any history of opioid use disorder.

Interventions

Subutex / Buprenorphine

Pregnant Mothers must be taking buprenorphine / subutex for opioid use disorder.

Fetal & Neonatal MRI

Mothers who consent will be given a fetal MRI and after the baby is born, a neonatal MRI.

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 measure

  • Incidence of opioid misuse severity using assessments [ Time Frame: 5 years ]
  • Pharmacological treatment for neonatal abstinence syndrome [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Senthil Sadhasivam, MD, MPH

4126474484sadhasivams@upmc.edu

Carly Riedmann, MPH

4126234147riedmannca@upmc.edu

Locations

UPMC Children's Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Senthil M Sadhasivam, MD, MPH

4126474484sadhasivams@upmc.edu

Carly Riedmann, MPH

4126234147riedmannca@upmc.edu

Principal Investigator:

Senthilkumar Sadhasivam, MD, MPH

More Information

Sponsor

Senthil Sadhasivam

Last update posted

Dec 18, 2025

Last verified

Dec, 2025

Keywords

  • Pregnant with Opioid Use Disorder
  • Opioid Use Disorder ( OUD)
  • Subutex
  • Buprenorphine
  • Pregnant taking buprenorphine/subutex

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Senthil Sadhasivam on 2025-12-18.