MOM NEST Study: Maternal Opioid Medication: Naltrexone Efficacy Study

Last updated: October 31, 2024
Sponsor: Boston Medical Center
Overall Status: Completed

Phase

N/A

Condition

Alcohol Use Disorder

Substance Abuse

Alcohol Dependence

Treatment

Pharmacokinetic analysis

Safety and Efficacy

Breast milk analysis

Clinical Study ID

NCT03718104
H-37773
R01HD096798-01
  • Ages > 18
  • Female

Study Summary

This is a multi-center prospective comparative cohort study examining the safety, efficacy, pharmacokinetics, and pharmacogenomics of naltrexone for pregnant women with opioid use disorder. Pregnancy, delivery, and maternal and infant outcomes to 12 months post-delivery will be examined and compared with a cohort treated with buprenorphine/naloxone.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pregnant women between 6 - 30 6/7 weeks gestation, receiving prenatal care at BostonMedical Center (BMC) or the University of North Carolina (UNC)

  • Plan to deliver infant at BMC or UNC

  • Diagnosis of opioid use disorder (OUD) or alcohol use disorder (AUD) in the currentpregnancy on prescribed oral or extended-release naltrexone; orbuprenorphine/naloxone for the treatment of OUD

  • English speaking

  • Singleton pregnancy

Exclusion

Exclusion Criteria:

  • OUD on prescribed methadone, or no maintenance medication

  • OUD on Subutex formulation of buprenorphine

  • Severe psychiatric illness or cognitively impairing ability to provide informedconsent

  • Current maternal incarceration

  • Women who present for care >31 0/7 weeks

  • Multiple gestation pregnancy

Study Design

Total Participants: 46
Treatment Group(s): 4
Primary Treatment: Pharmacokinetic analysis
Phase:
Study Start date:
December 01, 2018
Estimated Completion Date:
May 08, 2024

Study Description

Fifty pregnant women stabilized pre-pregnancy on oral or extended-release naltrexone (XR-NTX) and 50 comparison women on buprenorphine/naloxone (BPH) from Boston Medical Center and the University of North Carolina will be enrolled in this multi-center prospective comparative cohort study. The specific aims of this project are: 1) Safety and Efficacy: To compare maternal outcomes (safety, relapse, retention in care), fetal outcomes (growth, fetal distress), and infant outcomes (neonatal abstinence syndrome, growth, neurodevelopment) during pregnancy until 12 months post- delivery; An exploratory part of this aim is to collect safety and efficacy data on women receiving NTX for alcohol use disorder (AUD). We will collect maternal, fetal and infant outcomes related to prenatal alcohol exposure. 2) Pharmacokinetics: To determine the pharmacokinetics of NTX in pregnant and postpartum women; 3) Genetics and Epigenetics: To examine the association between genetic variants and epigenetic modification in the mu-opioid receptor (OPRM1) gene, as well as global DNA methylation changes after treatment with NTX and BPH within the mother, placenta, and infant; and 4) Breast milk: To measure breast milk concentrations of NTX and corresponding infant relative dose to determine safety for lactating women.

Connect with a study center

  • Boston Medical Center

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • University of North Carolina Chapel Hill

    Carrboro, North Carolina 27510
    United States

    Site Not Available

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