Safety, pharmacokinetics and efficacy of extended-release naltrexone in pregnant women with opioid use disorder
缓释纳曲酮对阿片类药物使用障碍孕妇的安全性、药代动力学和疗效
基本信息
- 批准号:10178062
- 负责人:
- 金额:$ 62.44万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2018
- 资助国家:美国
- 起止时间:2018-09-17 至 2023-05-31
- 项目状态:已结题
- 来源:
- 关键词:Adverse effectsAftercareAge-MonthsAgonistAllelesAnimalsBiological AssayBirthBloodBostonBrainBreast FeedingBuprenorphineCaringCohort StudiesDNA MethylationDataDevelopmentDoseDrug KineticsEffectivenessEnrollmentEpigenetic ProcessExcretory functionExposure toFemale of child bearing ageFetal DevelopmentFetal DistressFetusFutureGenesGeneticGenomicsGrowthHourHumanHuman MilkHydrocortisoneInfantInvestigationKidneyKnowledgeLactationLeftLifeMeasuresMedical SocietiesMedical centerMetabolismMethadoneMethylationModificationMonitorMothersNaltrexoneNamesNeonatal Abstinence SyndromeNeurodevelopmental ImpairmentNorth CarolinaOpiate AddictionOpioidOpioid AntagonistOpioid agonistOutcomeOverdosePatientsPharmaceutical PreparationsPharmacogeneticsPharmacogenomicsPlacentaPlasmaPolicy MakerPostpartum PeriodPostpartum WomenPregnancyPregnancy OutcomePregnant WomenPremature LaborProspective cohort studyProviderPublic HealthReceptor GeneRelapseRiskSafetySalivaSingle Nucleotide PolymorphismSpecial PopulationTimeUmbilical Cord BloodUncertaintyUniversitiesUrineWomanaddictionbuprenorphine treatmentcommon treatmentcomparativeeffective therapyfetalgenetic variantgenome wide methylationgenome-widehuman dataimprovedindividualized medicineinfant outcomematernal outcomemedication-assisted treatmentmu opioid receptorsneonatal outcomeneurodevelopmentnovelopioid agonist therapyopioid epidemicopioid use disorderoptimal treatmentspatient populationplacental transferpre-clinicalpregnantprenatal exposureprepregnancypromoterprospectivesafety studysocialstandard of caresuccess
项目摘要
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.
项目摘要
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Elisha Wachman其他文献
Elisha Wachman的其他文献
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{{ truncateString('Elisha Wachman', 18)}}的其他基金
Association of maternal, fetal and placental biomarkers with neonatal neuroimaging and development following in-utero opioid exposure
母体、胎儿和胎盘生物标志物与宫内阿片类药物暴露后新生儿神经影像和发育的关系
- 批准号:
10748626 - 财政年份:2023
- 资助金额:
$ 62.44万 - 项目类别:
Safety, Efficacy, Pharmacokinetics, and Pharmacogenomics of Extended-Release Naltrexone in Pregnant Women - Administrative Supplement
缓释纳曲酮在孕妇中的安全性、功效、药代动力学和药物基因组学 - 行政补充文件
- 批准号:
10620577 - 财政年份:2022
- 资助金额:
$ 62.44万 - 项目类别:
Safety, pharmacokinetics and efficacy of extended-release naltrexone in pregnant women with opioid use disorder
缓释纳曲酮对阿片类药物使用障碍孕妇的安全性、药代动力学和疗效
- 批准号:
10405099 - 财政年份:2018
- 资助金额:
$ 62.44万 - 项目类别:
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