# Pharmacologically-based Strategies for Buprenorphine Treatment During Pregnancy

> **NIH NIH R01** · MAGEE-WOMEN'S RES INST AND FOUNDATION · 2020 · $690,940

## Abstract

Title: Pharmacologically-based Strategies for Buprenorphine Treatment During Pregnancy
Abstract
This proposal will challenge several current clinical approaches to managing the pregnant woman with an
opioid use disorder. Dosing of buprenorphine (BUP) in pregnant women is based on studies in non-pregnant
subjects which suggests that symptoms of withdrawal occur when plasma BUP concentrations are < 1ng/ml.
No such data exist for pregnant women but this is a prerequisite for defining an appropriate dosing regimen of
BUP in pregnant women. We will define his threshold by monitoring women undergoing mild, medically
directed withdrawal. The Clinical Opioid Withdrawal Scale score and the Finnegan score for NAS are key to
defining when withdrawal occurs and thus dictate treatment in mother and baby. Neither scoring system is
based on plasma BUP concentrations and thus, may not reflect true opioid withdrawal. This proposal aims to
develop physiologic based scoring systems that refine the accuracy of diagnosis and optimizes treatment. The
risk of NAS is assumed to be unrelated to maternal or fetal exposure to opioids leading to a generous use of
opioid medications in medication-assisted treatment (MAT) programs. This assumption is based on a few small
studies with conflicting results. This relationship will be explored using a maternal and baby hair, placenta ,
cord and meconium as predictors of chronic maternal and fetal exposure as these are unaffected by maternal
truthfulness or acute dosing at the time of delivery. Contemporary thinking views medication-assisted treatment
(MAT) as the best strategy for pregnant women with an opioid use disorder. This strategy is based on fetal
concerns and the historically high risk of relapse with detoxification approaches. Recent data indicate that fetal
risk from detoxification to be minimal if any. Guidelines for detoxification do not currently exist. In this proposal
we aim to evaluate 3 components of detoxification that may impact the risk of cravings and relapse. We will
assess dose reduction quantity, dose reduction frequency and dosing frequency as each may impact the
success rate of detoxification. These 3 elements impact the magnitude of perturbations in plasma BUP
concentrations (a measure of BUP exposure) that occur with each dose reduction and the rate of
accommodation of opioid induced brain changes.

## Key facts

- **NIH application ID:** 9930463
- **Project number:** 5R01HD096796-03
- **Recipient organization:** MAGEE-WOMEN'S RES INST AND FOUNDATION
- **Principal Investigator:** STEVE N CARITIS
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $690,940
- **Award type:** 5
- **Project period:** 2018-09-17 → 2023-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9930463

## Citation

> US National Institutes of Health, RePORTER application 9930463, Pharmacologically-based Strategies for Buprenorphine Treatment During Pregnancy (5R01HD096796-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9930463. Licensed CC0.

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