# Safety, pharmacokinetics and efficacy of extended-release naltrexone in pregnant women with opioid use disorder

> **NIH NIH R01** · BOSTON MEDICAL CENTER · 2020 · $646,039

## Abstract

PROJECT ABSTRACT
Opioid use disorders (OUDs) in pregnancy are a US public health crisis; current standard of care is treatment
with an opioid agonist such as buprenorphine (BPH), shown to improve pregnancy outcomes however with an
associated risk for neonatal abstinence syndrome (NAS) and possible long-term neurodevelopmental
consequences. The opioid antagonist naltrexone represents a novel treatment option for OUD in pregnancy
which would not expose the developing fetus to opioids, greatly reducing the risk for NAS and potentially
improving maternal and infant outcomes. Preliminary animal and human studies demonstrate minimal impact
on pregnancy and fetal outcomes with naltrexone exposure, however there is an overall lack of prospective
human data fully evaluating safety, efficacy, and the full-range of maternal and infant outcomes. In addition, the
pharmacokinetics, pharmacogenomics, placental transfer, breast milk transfer and safety of naltrexone when
used during pregnancy and the postpartum period are unknown. We propose to fill these gaps in knowledge by
studying the safety, efficacy, pharmacokinetics, and pharmacogenomics of naltrexone for pregnant women
with OUDs, evaluating comprehensive mother-infant outcomes throughout the pregnancy and first year after
birth. We will enroll 50 pregnant women stabilized pre-pregnancy on extended-release naltrexone (XR-NTX)
and 50 comparison women on BPH from Boston Medical Center and the University of North Carolina in this
multi-centered 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 (NAS, growth, neurodevelopment) during pregnancy until 12 months post-
delivery; 2) Pharmacokinetics: To determine the pharmacokinetics of XR-NTX in pregnant and postpartum
women; 3) Genomics: 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 XR-NTX
and BPH within the mother, placenta, and infant; and 4) Breast milk: To measure breast milk concentrations of
XR-NTX and corresponding infant relative dose to determine safety for lactating women. We hypothesize that
XR-NTX will be demonstrated to be a safe and effective treatment option for pregnant and postpartum women
with OUD, with improved maternal and infant outcomes in comparison with opioid agonist treatment. The
results of this study hold the promise to guide planned future studies examining the use of both XR-NTX and
other agonist medications in the context of best practice treatment for OUD in pregnancy in order to improve
long-term maternal and infant outcomes.

## Key facts

- **NIH application ID:** 9934219
- **Project number:** 5R01HD096798-03
- **Recipient organization:** BOSTON MEDICAL CENTER
- **Principal Investigator:** Elisha Wachman
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $646,039
- **Award type:** 5
- **Project period:** 2018-09-17 → 2023-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9934219

## Citation

> US National Institutes of Health, RePORTER application 9934219, Safety, pharmacokinetics and efficacy of extended-release naltrexone in pregnant women with opioid use disorder (5R01HD096798-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9934219. Licensed CC0.

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