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Safety, Efficacy, Pharmacokinetics, and Pharmacogenomics of Extended-Release Naltrexone in Pregnant Women - Administrative Supplement

Award Number: R01HD096798
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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PROJECT ABSTRACT Opioid use disorders (OUDs) in pregnancy are a US public health crisis; current standard of care is treatment with an opioid agonist such as buprenorphine (BPH), shown to improve pregnancy outcomes however with an associated risk for neonatal abstinence syndrome (NAS) and possible long-term neurodevelopmental consequences. The opioid antagonist naltrexone represents a novel treatment option for OUD in pregnancy which would not expose the developing fetus to opioids, greatly reducing the risk for NAS and potentially improving maternal and infant outcomes. Preliminary animal and human studies demonstrate minimal impact on pregnancy and fetal outcomes with naltrexone exposure, however there is an overall lack of prospective human data fully evaluating safety, efficacy, and the full-range of maternal and infant outcomes. In addition, the pharmacokinetics, pharmacogenomics, placental transfer, breast milk transfer and safety of naltrexone when used during pregnancy and the postpartum period are unknown. We propose to fill these gaps in knowledge by studying the safety, efficacy, pharmacokinetics, and pharmacogenomics of naltrexone for pregnant women with OUDs, evaluating comprehensive mother-infant outcomes throughout the pregnancy and first year after birth. We will enroll 50 pregnant women stabilized pre-pregnancy on extended-release naltrexone (XR-NTX) and 50 comparison women on BPH from Boston Medical Center and the University of North Carolina in this multi-centered prospective comparative cohort study. The specific aims of this project are: 1) Safety and Efficacy: To compare maternal outcomes (safety, relapse, retention in care), fetal outcomes (growth, fetal distress), and infant outcomes (NAS, growth, neurodevelopment) during pregnancy until 12 months post- delivery; 2) Pharmacokinetics: To determine the pharmacokinetics of XR-NTX in pregnant and postpartum women; 3) Genomics: To examine the association between genetic variants and epigenetic modification in the mu-opioid receptor (OPRM1) gene, as well as global DNA methylation changes after treatment with XR-NTX and BPH within the mother, placenta, and infant; and 4) Breast milk: To measure breast milk concentrations of XR-NTX and corresponding infant relative dose to determine safety for lactating women. We hypothesize that XR-NTX will be demonstrated to be a safe and effective treatment option for pregnant and postpartum women with OUD, with improved maternal and infant outcomes in comparison with opioid agonist treatment. The results of this study hold the promise to guide planned future studies examining the use of both XR-NTX and other agonist medications in the context of best practice treatment for OUD in pregnancy in order to improve long-term maternal and infant outcomes.


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: 2025 ( Subtotal = -$2,669 )
2025	2022	BOSTON MEDICAL CENTER CORPORATION	1 BOSTON MEDICAL CTR PL	BOSTON	MA	02118	SUFFOLK	USA	Child Health and Human Development Extramural Research	001	5	10/17/2024	SUPPLEMENT FOR EXPANSION	-$438
2025	2022	BOSTON MEDICAL CENTER CORPORATION	1 BOSTON MEDICAL CTR PL	BOSTON	MA	02118	SUFFOLK	USA	Child Health and Human Development Extramural Research	000	5	10/17/2024	NON-COMPETING CONTINUATION	-$2,231
														Subtotal = -$2,669

Issue Date FY: 2022 ( Subtotal = $734,138 )
2022	2022	BOSTON MEDICAL CENTER CORPORATION	1 BOSTON MEDICAL CTR PL STE 1	BOSTON	MA	02118	SUFFOLK	USA	Child Health and Human Development Extramural Research	001	5	7/22/2022	SUPPLEMENT FOR EXPANSION	$120,476
2022	2022	BOSTON MEDICAL CENTER CORPORATION	1 BOSTON MEDICAL CTR PL STE 1	BOSTON	MA	02118	SUFFOLK	USA	Child Health and Human Development Extramural Research	000	5	5/9/2022	NON-COMPETING CONTINUATION	$613,662
														Subtotal = $734,138

Issue Date FY: 2021 ( Subtotal = $624,404 )
2021	2021	BOSTON MEDICAL CENTER CORPORATION	1 BOSTON MEDICAL CENTER PL STE 1	BOSTON	MA	02118	SUFFOLK	USA	Child Health and Human Development Extramural Research	000	4	5/13/2021	NON-COMPETING CONTINUATION	$624,404
														Subtotal = $624,404

Issue Date FY: 2020 ( Subtotal = $646,039 )
2020	2020	BOSTON MEDICAL CENTER CORPORATION	1 BOSTON MEDICAL CENTER PL STE 1	BOSTON	MA	02118	SUFFOLK	USA	Child Health and Human Development Extramural Research	000	3	6/1/2020	NON-COMPETING CONTINUATION	$646,039
														Subtotal = $646,039

Issue Date FY: 2019 ( Subtotal = $667,852 )
2019	2019	BOSTON MEDICAL CENTER CORPORATION	1 BOSTON MEDICAL CENTER PL STE 1	BOSTON	MA	02118	SUFFOLK	USA	Child Health and Human Development Extramural Research	000	2	5/23/2019	NON-COMPETING CONTINUATION	$667,852
														Subtotal = $667,852

Issue Date FY: 2018 ( Subtotal = $722,799 )
2018	2018	BOSTON MEDICAL CENTER CORPORATION	1 BOSTON MEDICAL CENTER PL STE 1	BOSTON	MA	02118	SUFFOLK	USA	Child Health and Human Development Extramural Research	000	1	9/17/2018	NEW	$722,799
														Subtotal = $722,799

Grand Total All Awards = $3,392,563

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Safety, Efficacy, Pharmacokinetics, and Pharmacogenomics of Extended-Release Naltrexone in Pregnant Women - Administrative Supplement

Award Number: R01HD096798

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

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