# Medically-supervised withdrawal vs. agonist maintenance in the treatment of pregnant women with opioid use disorder: Maternal, fetal, and neonatal outcomes

> **NIH NIH R01** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2022 · $649,921

## Abstract

PROJECT SUMMARY/ABSTRACT
Background. Recommendations for opioid agonist treatment (OAT) and against medically-supervised
withdrawal (MSW) were based on early reports associating withdrawal with maternal relapse and fetal
demise. While our recent systematic review did not support an association between MSW and fetal demise,
relapse remains a significant concern with rates ranging from 0% to 100%. A retrospective report also
suggests more delivery complications at delivery with MSW as compared to OAT. Neonatal outcomes after
maternal MSW, however, are more positive, with retrospective reports suggesting MSW decreases the
incidence of neonatal abstinence syndrome (NAS), reduces the amount of medication needed to treat NAS,
and shortens neonatal length of hospital stay as compared to OAT. Given the literature’s mixed findings and
methodological weaknesses, controlled prospective studies are needed.
Study Design. The proposed study will be a four site, controlled, prospective, longitudinal, matched cohort
study in which pregnant women with OUD who choose MSW at treatment entry (n=120) will be propensity-
score matched with pregnant women with OUD who choose OAT at treatment entry (n=240) using maternal
demographic, social, personal, and substance use history data collected at study entry. Women choosing
MSW will undergo a 5-7 day withdrawal using buprenorphine; those choosing OAT will be inducted onto
buprenorphine. All will receive comprehensive clinical care (obstetrical visits, group and individual
counseling, case management, psychiatry services, and urine drug screening) and complete monthly
research assessments with study staff. There will be a full assessment of maternal and neonatal health and
well-being at birth, a minimum 4-day assessment of NAS, and a maternal postpartum assessment.
Aim 1: (Exploratory) To determine the extent to which pregnant women with OUD seeking MSW differ from
those seeking OAT in terms of demographic, social, personal, and substance use history characteristics.
Aim 2: (Inferential) To examine the extent to which pregnant women with OUD seeking MSW differ from
those seeking OAT in terms of maternal and neonatal outcomes. Aim 3. (Descriptive) To assess the ability
of participant treatment entry characteristics to discriminate between (a) MSW participants who successfully
complete their withdrawal protocol from MSW participants who do not; (b) MSW participants who
successfully complete MSW and are opioid-negative at delivery from MSW participants who successfully
complete their withdrawal protocol but discontinue treatment and are opioid-positive at delivery; and (c)
participants who successfully complete MSW and are opioid-negative at delivery from participants who
remain in OAT and are opioid-negative at delivery. Public Health Impact. This study will provide science-
based evidence that addresses significant gaps in the treatment of OUD during pregnancy to be used by
government, medical societies, providers and patie...

## Key facts

- **NIH application ID:** 10375543
- **Project number:** 5R01DA047867-05
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** Sarah H Heil
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $649,921
- **Award type:** 5
- **Project period:** 2018-07-15 → 2026-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10375543

## Citation

> US National Institutes of Health, RePORTER application 10375543, Medically-supervised withdrawal vs. agonist maintenance in the treatment of pregnant women with opioid use disorder: Maternal, fetal, and neonatal outcomes (5R01DA047867-05). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10375543. Licensed CC0.

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