# Maternal buprenorphine-naloxone treatment during the perinatal period: Fetal and infant effects

> **NIH NIH R01** · JOHNS HOPKINS UNIVERSITY · 2022 · $582,867

## Abstract

Project Summary
Medical, psychosocial and financial problems associated with prenatal opioid dependency and Neonatal
Abstinence Syndrome (NAS) have reached epidemic proportions in the US. Solutions include optimizing the
treatment for opioid dependent pregnant women while mitigating the severity of NAS and other
neurobehavioral consequences of prenatal opioid exposure. Currently, only methadone maintenance is offered
standardly, with more providers prescribing buprenorphine-only in the US due to milder NAS. Methadone
treatment, although advantageous for many women, is a difficult choice due to the frequency and severity of
the NAS. Buprenorphine-only has a high diversion/abuse potential, is not always readily availble, and can
have unpleasant side effects in some women. Buprenorphine-naloxone (B+N) treatment of pregnant women
may be an attractive and effective strategy due to the antagonist component, which can result in reduced
abuse liability, reduced risk of diversion and increased drug effectiveness by increasing medicaiton adherence,
all of which can serve to decrease NAS severity. However, there are currently no published reports that
provide a prospective assessment of maternal, fetal and infant functioning with maternal B+N maintenance.
Similarly, there is no data available today to support lactation – another strategy to reduce the severity of NAS
expresssion - in B+N maintained women.
The purpose of this mechanistic study is to evaluate the effects that maternal B+N maintenance have on the
neurobehavioral development of the fetus and infant. To accomplish this, we will study a sample of 120 opioid
dependent pregnant women that will receive B+N as part of substance abuse treatment at a comprehensive
care treatment facility for pregnant and parenting women with substance use disorders. Fetal neurobehavior
and maternal physiology will be assessed, via an established maternal-fetal data acquisition system, at 4
points during gestation: 24, 28, 32 and 36 weeks. Infant birth parameters and NAS spectrum display will be
evaluated at birth, and infant neurodevelopment will be assessed during the first month of life. We will compare
the neurodevelopment of the B+N-exposed fetuses and infants to that of methadone and buprenorphine-only
exposed fetuses and infants. In addition, concentrations of B+N in breast milk, maternal and infant plasma
among breastfeeding women maintained on B+N will be determined. NAS parameters and neurobehavioral
profiles of B+N breastfed infants will be compared to B+N exposed formula fed infants.

## Key facts

- **NIH application ID:** 10307111
- **Project number:** 5R01DA041367-05
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** LAUREN M JANSSON
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $582,867
- **Award type:** 5
- **Project period:** 2017-09-15 → 2024-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10307111

## Citation

> US National Institutes of Health, RePORTER application 10307111, Maternal buprenorphine-naloxone treatment during the perinatal period: Fetal and infant effects (5R01DA041367-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10307111. Licensed CC0.

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