# The Comparative Effectiveness and Safety of Pharmacotherapies for the Treatment of Opioid Use Disorder in Pregnancy

> **NIH NIH R01** · BRIGHAM AND WOMEN'S HOSPITAL · 2022 · $688,134

## Abstract

ABSTRACT
 The frequency of opioid use disorders (OUD) during pregnancy has increased substantially during the
past two decades, reflecting the risk observed in the general population. The current recommendation from
guideline groups is that pregnant women with OUD be treated with opioid agonist therapy (OAT). OAT has
been shown to improve pregnancy outcomes in women with OUD because it prevents opioid withdrawal
symptoms that can be disruptive to fetal well-being and to reduce illicit opioid and other substance use.
Methadone has historically been the mainstay of OUD treatment during pregnancy. However, in recent years,
buprenorphine use has increased and is now used in approximately equal measure with methadone.
 Methadone and buprenorphine have different pharmacologic effects. The way in which these
treatments are administered is also different. Methadone is dispensed under observation via a federally-
regulated opioid treatment program. In contrast, buprenorphine is generally dispensed by prescription in a
routine office-based setting. Buprenorphine also comes in two formulations, as a monoproduct and in
combination with naloxone, an opioid antagonist, which is intended to deter misuse via injection. Comparative
safety and effectiveness data for pharmacologic approaches to the treatment of OUD in pregnancy are very
limited. The MOTHER trial demonstrated that buprenorphine is associated with less severe neonatal
abstinence syndrome compared to methadone. Data regarding the comparative safety of buprenorphine and
methadone with respect to other adverse pregnancy outcomes and the impact on long-term neurodevelopment
are few and subject to a number of potential biases and limitations. The comparative effectiveness of
buprenorphine and methadone with respect to retention in treatment and impact on adequacy of prenatal care
has also not been fully defined. For those prescribed buprenorphine in pregnancy, the use of the monoproduct
is generally recommended, despite the higher risk for misuse, because there are few data regarding the safety
of the combination product which includes naloxone.
 The overall goal of this study is to utilize state of the art design and analytic epidemiological methods
applied to a large cohort of women defined using nationwide Medicaid data to generate the best possible
evidence regarding the comparative safety and effectiveness of medications used to treat OUD in pregnancy.
Specific methods that we intend to employ include propensity score fine stratification, high-dimensional
propensity score adjustment, alternative referents (discontinuer comparisons), and bias analyses to account for
potential misclassification of exposure and outcome and residual confounding. The results of the studies are
expected to have an important and direct clinical impact guiding clinicians’ and patients’ selection of the best
treatment for OUD in order to ensure a good outcome for mothers and their children.

## Key facts

- **NIH application ID:** 10319626
- **Project number:** 5R01DA049822-03
- **Recipient organization:** BRIGHAM AND WOMEN'S HOSPITAL
- **Principal Investigator:** Brian Thomas Bateman
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $688,134
- **Award type:** 5
- **Project period:** 2020-04-01 → 2023-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10319626

## Citation

> US National Institutes of Health, RePORTER application 10319626, The Comparative Effectiveness and Safety of Pharmacotherapies for the Treatment of Opioid Use Disorder in Pregnancy (5R01DA049822-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10319626. Licensed CC0.

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