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Pharmacologically-based Strategies for Buprenorphine Treatment During Pregnancy

Award Number: R01HD096796
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/17/2018
PERIOD OF PERFORMANCE END DATE: 05/31/2025

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Pharmacologically-based Strategies for Buprenorphine Treatment During Pregnancy - 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = -$35,796 )
2026	2022	MAGEE-WOMENS RESEARCH INSTITUTE AND FOUNDATION	3240 CRAFT PL STE 100	PITTSBURGH	PA	15213	ALLEGHENY	USA	Child Health and Human Development Extramural Research	000	5	11/24/2025	NON-COMPETING CONTINUATION	-$35,796
														Subtotal = -$35,796

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2022	MAGEE-WOMENS RESEARCH INSTITUTE AND FOUNDATION	3240 CRAFT PL STE 100	PITTSBURGH	PA	15213	ALLEGHENY	USA	Child Health and Human Development Extramural Research	000	5	5/24/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	MAGEE-WOMENS RESEARCH INSTITUTE AND FOUNDATION	3339 WARD ST	PITTSBURGH	PA	15213	ALLEGHENY	USA	Child Health and Human Development Extramural Research	000	5	12/8/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $643,449 )
2022	2022	MAGEE-WOMENS RESEARCH INSTITUTE AND FOUNDATION	3339 WARD ST	PITTSBURGH	PA	15213	ALLEGHENY	USA	Child Health and Human Development Extramural Research	000	5	6/2/2022	NON-COMPETING CONTINUATION	$643,449
														Subtotal = $643,449

Issue Date FY: 2021 ( Subtotal = $667,106 )
2021	2021	MAGEE-WOMENS RESEARCH INSTITUTE AND FOUNDATION	3339 WARD ST	PITTSBURGH	PA	15213	ALLEGHENY	USA	Child Health and Human Development Extramural Research	000	4	6/3/2021	NON-COMPETING CONTINUATION	$667,106
														Subtotal = $667,106

Issue Date FY: 2020 ( Subtotal = $690,940 )
2020	2020	MAGEE-WOMENS RESEARCH INSTITUTE AND FOUNDATION	3339 WARD ST	PITTSBURGH	PA	15213	ALLEGHENY	USA	Child Health and Human Development Extramural Research	000	3	4/28/2020	NON-COMPETING CONTINUATION	$690,940
														Subtotal = $690,940

Issue Date FY: 2019 ( Subtotal = $693,229 )
2019	2019	MAGEE-WOMENS RESEARCH INSTITUTE AND FOUNDATION	3339 WARD ST	PITTSBURGH	PA	15213	ALLEGHENY	USA	Child Health and Human Development Extramural Research	001	2	5/15/2019	NON-COMPETING CONTINUATION	$693,229
2019	2018	MAGEE-WOMENS RESEARCH INSTITUTE AND FOUNDATION	3339 WARD ST	PITTSBURGH	PA	15213	ALLEGHENY	USA	Child Health and Human Development Extramural Research	000	1	1/25/2019	NEW	$0
														Subtotal = $693,229

Issue Date FY: 2018 ( Subtotal = $716,681 )
2018	2018	MAGEE-WOMENS RESEARCH INSTITUTE AND FOUNDATION	3339 WARD ST	PITTSBURGH	PA	15213	ALLEGHENY	USA	Child Health and Human Development Extramural Research	000	1	9/17/2018	NEW	$716,681
														Subtotal = $716,681

Grand Total All Awards = $3,375,609

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Pharmacologically-based Strategies for Buprenorphine Treatment During Pregnancy

Award Number: R01HD096796

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/17/2018

PERIOD OF PERFORMANCE END DATE: 05/31/2025

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