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

  • Clinicaltrials.gov identifier

    NCT03923374

  • Recruitment Status

    Recruiting

  • First Posted

    April 22, 2019

  • Last update posted

    July 28, 2020

Study Description

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).

  • Condition or Disease:Opioid-use Disorder
    Opioid Use, Unspecified
    Buprenorphine Dependence
  • Intervention/Treatment: Drug: Subutex / Buprenorphine
    Diagnostic Test: Fetal & Neonatal MRI
    Diagnostic Test: DNA/Genetic/Pharmacokenetic Blood Draws
  • Phase: N/A

Detailed Description

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.

Study Design

  • Study Type: Observational [Patient Registry]
  • Estimated Enrollment: 300 participants
  • Observational Model: Other
  • Time Perspective: Prospective
  • Official Title: Effects of Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
  • Actual Study Start Date: September 2018
  • Estimated Primary Completion Date: June 2023
  • Estimated Study Completion Date: June 2023

Groups and Cohorts

Groups/Cohorts Intervention/treatment
: 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
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.
: Pregnant Mothers
Planned recruitment of 100 pregnant (>16weeks) mothers who do not have any history of 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.

Outcome Measures

  • Primary Outcome Measures: 1. 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.
  • 2. Pharmacological treatment for neonatal abstinence syndrome [ Time Frame: 5 years ]
    Incidence of Neonatal Abstinence Syndrome and need for pharmacological treatment.
  • Secondary Outcome Measures: 1. Incidence of adverse effects of buprenorphine using MRI [ Time Frame: 5 years ]
    Incidence of adverse effects of buprenorphine use on fetal and placental changes using MRI.
  • 2. Concentration of long-term neurodevelopmental outcomes using assessments [ Time Frame: 5 years ]
    Concentration of long-term neurodevelopmental outcomes in neonates using the Ages and Stages Questionnaire and the Baileys follow-up assessment.
  • Biospecimen Retention: Samples With DNA

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

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: Yes
  • 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.

Criteria

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.

Contacts and Locations

Contacts

Contact: Senthil Sadhasivam, MD 317-948-3845 ssadhasivam@IUHealth.org

Locations

United States, Indiana
Riley Hospital for Children; Anesthesia Department
Indianapolis

Sponsors and Collaborators

Indiana University

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute on Drug Abuse (NIDA)

More Information

  • Responsible Party: Indiana University
  • ClinicalTrials.gov Identifier: NCT03923374 History of Changes
  • Other Study ID Numbers: 1807356299, 1R01HD096800-01
  • First Posted: April 22, 2019 Key Record Dates
  • Last Update Posted: July 28, 2020
  • Last Verified: July 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: Undecided
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Indiana University: Subutex
    Buprenorphine
    Pregnant with Opioid Use Disorder
    Pregnant taking buprenorphine/subutex
    Opioid Use Disorder ( OUD)
  • Additional relevant MeSH terms: Substance-Related Disorders Disease