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

> **NIH NIH R01** · BRIGHAM AND WOMEN'S HOSPITAL · 2024 · $839,898

## Abstract

The prevalence of opioid use disorder (OUD) in pregnancy has risen markedly in the United States over the
past two decades, reflecting trends observed in the general population. Guidelines recommend that pregnant
patients with OUD should receive medications for opioid use disorder (MOUD) during pregnancy to reduce the
risk of illicit opioid use and to improve fetal and maternal outcomes.
In the context of R01 DA049822, we found that buprenorphine use during pregnancy compared to methadone
is associated with a lower risk of neonatal abstinence syndrome, preterm delivery, small-for-gestational age, as
and most congenital defects. However, we also found that retention in MOUD treatment during pregnancy and
the postpartum period is suboptimal, particularly for buprenorphine, and lack of treatment in the postpartum
period is associated with a markedly higher risk of maternal overdose death. Co-exposure to psychotropics is
highly prevalent in pregnant patients treated with MOUD, with 54% being co-exposed. Likewise, non-opioid
substance use disorders are common in those treated with MOUD: 8% are diagnosed with illicit stimulant use,
8% with cocaine use disorder, 14% with cannabis use disorder, and 7% with alcohol use disorder.
Given plausible pharmacodynamic and pharmacokinetic mechanisms by which these co-exposures might
affect the comparative safety and effectiveness of MOUD treatments, there is a need to better understand
risks associated with co-exposure to psychotropic medications and non-opioid substance use
disorders and how they should impact the choice of MOUD. The recent surge of highly potent fentanyl in
the drug supply also introduces complexity into treatment decisions regarding type of MOUD and optimal
treatment protocols that needs to be evaluated. The suboptimal retention in MOUD treatment points to the
need to identify modifiable factors that can improve treatment retention (including provider, medication
dosing and dispensing schedule, and care delivery model), and thus maternal and neonatal outcomes. Finally,
the use of naltrexone to treat OUD has increased rapidly in recent years in women of reproductive age, leading
to a rapid rise in pregnancy exposure. Yet very few data are available regarding the safety of use during
pregnancy, creating a critical gap in the evidence needed to guide the growing number of pregnant
patients (or those planning pregnancy) who have been successfully treated with naltrexone.
In this competing renewal application, we propose to build on the team’s significant experience studying OUD
treatments to address these newly emerging critical gaps in evidence. We will use state-of-the-art and
innovative epidemiological methods applied to large nationwide cohorts of publicly and commercially insured
pregnancies that are continuously updated. The resulting evidence will help steer providers toward the optimal
treatment choice for individual patients and will identify factors that can be intervened upon directly to...

## Key facts

- **NIH application ID:** 11046753
- **Project number:** 2R01DA049822-05
- **Recipient organization:** BRIGHAM AND WOMEN'S HOSPITAL
- **Principal Investigator:** Brian Thomas Bateman
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $839,898
- **Award type:** 2
- **Project period:** 2020-04-01 → 2029-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11046753

## Citation

> US National Institutes of Health, RePORTER application 11046753, The Comparative Effectiveness and Safety of Pharmacotherapies for the Treatment of Opioid Use Disorder in Pregnancy (2R01DA049822-05). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/11046753. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*