Pharmacokinetics of Oral and Extended-release Naltrexone in Pregnant and Lactating Individuals and their Infants.

IF 4.2 3区 医学 Q1 SUBSTANCE ABUSE
Nicole Iannella, Jeremiah Momper, Mark Mirochnick, Raymond T Suhandynata, Kelley Saia, Martha Werler, Hendree E Jones, Elisha M Wachman
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引用次数: 0

Abstract

Objectives: Naltrexone may be utilized for the treatment of opioid and/or alcohol use disorder during pregnancy. However, limited information is available on the pharmacokinetics of naltrexone during pregnancy and lactation. The objective of this study was to evaluate maternal and infant concentrations of naltrexone and its major metabolite 6β-naltrexol in relevant matrices across pregnancy and the immediate postpartum period.

Methods: Pregnant individuals receiving naltrexone were enrolled in this prospective cohort study. Maternal plasma and urine samples were collected serially during pregnancy at up to 6 time points. At delivery, cord blood, maternal plasma, infant plasma, and infant urine were collected. Four weeks after delivery, breastmilk, maternal plasma, and infant plasma samples were collected. All samples were analyzed for naltrexone and 6β-naltrexol using a validated liquid chromatography tandem mass spectrometry assay.

Results: A total of 7 pregnant individuals were enrolled: 4 receiving extended-release and 3 receiving oral naltrexone. Concentrations of naltrexone in maternal plasma in pregnancy remained detectable across the dosing interval for both formulations. The ratio of median cord blood to maternal plasma concentration was 1.11 in the extended-release and 0.74 in the oral group. Of the 7 infants, 1 remained breastfed at 4 weeks. The relative infant naltrexone dose via breastmilk at 31 days after delivery from the 1 infant was 0.83%.

Conclusions: While limited due to sample size, these data provide valuable information about the pharmacokinetics of prenatal use of naltrexone and perinatal transfer, guiding counseling and clinical management of the parent-infant dyad.

口服和缓释纳曲酮在孕妇和哺乳期个体及其婴儿中的药代动力学。
目的:纳曲酮可用于治疗妊娠期间阿片类药物和/或酒精使用障碍。然而,关于纳曲酮在妊娠期和哺乳期的药代动力学信息有限。本研究的目的是评估母婴纳曲酮及其主要代谢物6β-纳曲醇在孕期和产后相关基质中的浓度。方法:接受纳曲酮治疗的孕妇被纳入这项前瞻性队列研究。在怀孕期间连续采集孕妇血浆和尿液样本,最多采集6个时间点。分娩时采集脐带血、产妇血浆、婴儿血浆和婴儿尿液。分娩后4周,采集母乳、母体血浆和婴儿血浆样本。所有样品采用有效的液相色谱串联质谱法分析纳曲酮和6β-纳曲醇。结果:共纳入7例孕妇:4例接受缓释治疗,3例口服纳曲酮治疗。孕妇血浆中纳曲酮的浓度在两种剂型的给药间隔内仍可检测到。缓释组脐带血与母体血浆中位浓度之比为1.11,口服组为0.74。在这7名婴儿中,有1名在4周时仍然母乳喂养。1名婴儿分娩后31天母乳喂养的相对婴儿纳曲酮剂量为0.83%。结论:虽然样本量有限,但这些数据为产前使用纳曲酮和围产期转移的药代动力学提供了有价值的信息,指导了亲子对的咨询和临床管理。
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来源期刊
Journal of Addiction Medicine
Journal of Addiction Medicine 医学-药物滥用
CiteScore
6.10
自引率
9.10%
发文量
260
审稿时长
>12 weeks
期刊介绍: The mission of Journal of Addiction Medicine, the official peer-reviewed journal of the American Society of Addiction Medicine, is to promote excellence in the practice of addiction medicine and in clinical research as well as to support Addiction Medicine as a mainstream medical sub-specialty. Under the guidance of an esteemed Editorial Board, peer-reviewed articles published in the Journal focus on developments in addiction medicine as well as on treatment innovations and ethical, economic, forensic, and social topics including: •addiction and substance use in pregnancy •adolescent addiction and at-risk use •the drug-exposed neonate •pharmacology •all psychoactive substances relevant to addiction, including alcohol, nicotine, caffeine, marijuana, opioids, stimulants and other prescription and illicit substances •diagnosis •neuroimaging techniques •treatment of special populations •treatment, early intervention and prevention of alcohol and drug use disorders •methodological issues in addiction research •pain and addiction, prescription drug use disorder •co-occurring addiction, medical and psychiatric disorders •pathological gambling disorder, sexual and other behavioral addictions •pathophysiology of addiction •behavioral and pharmacological treatments •issues in graduate medical education •recovery •health services delivery •ethical, legal and liability issues in addiction medicine practice •drug testing •self- and mutual-help.
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