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Pregnant Mothers with Opioid Use Disorder for Drug Addiction

N/A
Waitlist Available
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after birth through one year of life
Awards & highlights

Summary

The goal of this observational study is to learn about the long term effects of prenatal opioid exposure. The main objectives are: * Long term goal: to improve the safety and efficacy of maternal Opioid Use Disorder (OUD) and eliminate neonatal opioid withdrawal syndrome (NOWS) and poor childhood neurodevelopment. * To characterize prenatal opioid exposure (POE) related placental and fetal brain structural and functional disruptions using longitudinal placenta-fetal brain magnetic resonance imaging (MRI) and determine proteomic, genomic, and epigenetic signatures of NOWS and poor infant neurodevelopment. In this study participants will: * Receive two placental-fetal MRIs, one during second trimester and one in third trimester. * Answer surveys relating to their medical and social history. * Have blood drawn during pregnancy and delivery. * Child development follow up: answer surveys on their child's development milestones and at one year of life they will undergo a development assessment.

Eligible Conditions
  • Drug Addiction
  • Substance Use Disorders
  • Pregnancy
  • Narcotic Use Disorder
  • Buprenorphine Dependence
  • Methadone Addiction
  • Opioid Use Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after birth through one year of life
This trial's timeline: 3 weeks for screening, Varies for treatment, and after birth through one year of life for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Alterations in fetal brain volume
Differences in placenta signal
Secondary study objectives
Ages and Stages Questionnaire Scores during infancy
Length of Hospital Stay
Neonatal Opioid Withdrawal Syndrome (NOWS) severity
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Pregnant Mothers with Opioid Use DisorderExperimental Treatment5 Interventions
150 pregnant mothers with opioid use disorder who are on buprenorphine or methadone treatment
Group II: Pregnant MothersExperimental Treatment4 Interventions
100 pregnant mother who to not have a history of opioid use disorder
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Questionnaires
2013
Completed Phase 2
~3330

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
1,019 Previous Clinical Trials
1,113,965 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,543 Previous Clinical Trials
3,249,126 Total Patients Enrolled
~167 spots leftby Dec 2028