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

NCT03923374 | Recruiting FDA Drug

• 2 other identifiers: STUDY211101121R01HD096800-01
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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, Unspecified; Opioid-use Disorder; Buprenorphine Dependence

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  5 years

• Pharmacological treatment for neonatal abstinence syndrome

  Incidence of Neonatal Abstinence Syndrome and need for pharmacological treatment.

  5 years

Secondary Outcomes (2)

• Incidence of adverse effects of buprenorphine using MRI

  5 years

• Concentration of long-term neurodevelopmental outcomes using assessments

  5 years

Study Arms (2)

Pregnant Mothers with Opioid Use Disorder

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

Pregnant Mothers

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

Interventions

Subutex / Buprenorphine DRUG

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

Pregnant Mothers with Opioid Use Disorder

Fetal & Neonatal MRI DIAGNOSTIC_TEST

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

Pregnant Mothers; Pregnant Mothers with Opioid Use Disorder

DNA/Genetic/Pharmacokenetic Blood Draws DIAGNOSTIC_TEST

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.

Pregnant Mothers; Pregnant Mothers with Opioid Use Disorder

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any woman of the age of 18 or older that is having a single pregnancy, and currently taking buprenorphine for opioid use disorder.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Senthil Sadhasivam: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

UPMC Children's Hospital

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Collection of DNA/Genetic/Epigenetic Samples from the mother at enrollment, then the infant at birth.

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Senthil Sadhasivam, MD, MPH

  University of Pittsburgh, UPMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Senthil Sadhasivam, MD, MPH

CONTACT

4126474484; sadhasivams@upmc.edu

Carly Riedmann, MPH

CONTACT

4126234147; riedmannca@upmc.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: April 22, 2019
• Study Start: September 15, 2018
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

US (1)