Evidence map›Paper›PMID 40388713›Full record

ArticleJournal of addiction medicine

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

Nicole Iannella, Jeremiah Momper, Mark Mirochnick, Raymond T Suhandynata, Kelley Saia, Martha Werler, Hendree E Jones, Elisha M Wachman

Abstract read
In one paragraph

Article in Journal of addiction medicine. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Nicole Iannella
Jeremiah Momper
Mark Mirochnick
Raymond T Suhandynata
Kelley Saia
Martha Werler
Hendree E Jones
Elisha M Wachman

Funding

Safety, pharmacokinetics and efficacy of extended-release naltrexone in pregnant women with opioid use disorderR01HD096798 · NICHD · BOSTON MEDICAL CENTER · PI WACHMAN, ELISHA · 2018 to 2022
$3.4M
NICHD NIH HHS R01 HD096798
6 · The paper itself

Abstract

objectivesNaltrexone 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.

methodsPregnant 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.

resultsA 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%.

conclusionsWhile 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.

Indexed as

LactationNaltrexoneNarcotic AntagonistsPregnancy ComplicationsAdministration, OralAdultBreast FeedingDelayed-Action PreparationsFemaleFetal BloodHumansInfantInfant, NewbornMilk, HumanOpioid-Related DisordersPregnancy6 beta-hydroxynaltrexoneDelayed-Action PreparationsNaltrexoneNarcotic Antagonistsalcohol use disorderbreastmilkopioid use disorderpharmacokineticspregnancy

Identifiers

PMID40388713
PMCPMC13261366

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.