Evidence map›Paper›PMID 31358302›Full record

ArticleClinical therapeutics2019

Naltrexone Treatment for Pregnant Women With Opioid Use Disorder Compared With Matched Buprenorphine Control Subjects.

Elisha M Wachman, Kelley Saia, Melissa Miller, Eduardo Valle, Hira Shrestha, Ginny Carter, Martha Werler, Hendree Jones

Registry-linked trialOpen access · bronzeAbstract readComparative Study
In one paragraph

Article in Clinical therapeutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03718104 (Safety, Efficacy, Pharmacokinetics, and Pharmacogenomics of Extended-Release Naltrexone in Pregnant Women), which is not on this map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
7.3field-weighted citation impact, top 3% of its field
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.

NCT03718104 completednot on this map

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

TypeobservationalSponsorBoston Medical CenterRan2018 to 2024Enrolled46ConditionsOpioid-use Disorder, Neonatal Abstinence Syndrome, Pregnancy, High Risk, Alcohol Use DisorderArmsPharmacokinetic analysis, Safety and Efficacy, Genetic and epigenetic analysis, Breast milk analysis
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 44 citations in OpenAlex.

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  10. Integrated Review of the Assessment of Newborns With Neonatal Abstinence Syndrome.Journal of obstetric, gynecologic, and neonatal nursing : JOGNN · 2021
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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 at 3 institutions in 1 country.

Elisha M WachmanDepartment of Pediatrics, Boston Medical Center, Boston, MA, USA; Grayken Center for Addiction Medicine, Boston Medical Center, Boston, MA, USA. Electronic address: elisha.wachman@bmc.org.
Kelley SaiaGrayken Center for Addiction Medicine, Boston Medical Center, Boston, MA, USA; Department of Obstetrics and Gynecology, Boston Medical Center, Boston, MA, USA.
Melissa MillerBoston University School of Public Health, Boston, MA, USA.
Eduardo ValleDepartment of Pediatrics, Boston Medical Center, Boston, MA, USA; Department of Obstetrics and Gynecology, Boston Medical Center, Boston, MA, USA.
Hira ShresthaDepartment of Pediatrics, Boston Medical Center, Boston, MA, USA.
Ginny CarterUNC Horizons and Department of Obstetrics and Gynecology, School of Medicine, University of North Carolina at Chapel Hill, Carrboro, NC, USA.
Martha WerlerBoston University School of Public Health, Boston, MA, USA.
Hendree JonesUNC Horizons and Department of Obstetrics and Gynecology, School of Medicine, University of North Carolina at Chapel Hill, Carrboro, NC, USA.
Boston Medical Center · USBoston University · USUniversity of North Carolina at Chapel Hill · US

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

purposeThe use of the opioid antagonist naltrexone (NTX) for pregnant women with opioid use disorder (OUD) remains understudied. The purpose of this pilot study was to examine pregnancy and neonatal outcomes in a cohort of NTX-treated women.

methodsThis single-center, retrospective cohort study included 6 mother-infant dyads taking NTX compared with 13 taking buprenorphine (BUP) between 2017 and 2019. Maternal demographic characteristics, any unprescribed or illicit opioid use per urine toxicology or provider report during the pregnancy or 6 months' postdelivery, delivery outcomes, gestational age, birth weight, Apgar scores, neonatal intensive care unit admission, and neonatal abstinence syndrome (NAS) outcomes (NAS diagnosis, pharmacologic treatment, and total hospital length of stay) were compared.

findingsMaternal and infant demographic characteristics were similar between the 2 groups, with the exception of cigarette smoking in the BUP group being more common (92% vs 33%; P = 0.02). None of the women on NTX versus 23% of the women on BUP had documented opioid misuse (P = 0.52). No infants in the NTX group had a NAS diagnosis versus 92% in the BUP group (P < 0.001). Forty-six percent of the BUP-exposed infants were treated for NAS versus 0% in the NTX group (P < 0.001). NTX-exposed infants had a shorter length of stay (mean [SD], 3.2 [1.6] vs 10.9 [8.2] days; P = 0.008). IMPLICATIONS: Maintaining women on NTX during pregnancy was associated with favorable outcomes. These results support the need for larger multicenter studies sufficiently powered to detect possible differences between the medications on long-term maternal and child safety and efficacy outcomes.

Indexed as

AdultAnalgesics, OpioidBuprenorphineFemaleHumansInfant, NewbornNaltrexoneNarcotic AntagonistsOpiate Substitution TreatmentOpioid-Related DisordersPilot ProjectsPregnancyPregnancy ComplicationsPregnancy OutcomeRetrospective StudiesTreatment OutcomeAnalgesics, OpioidBuprenorphineNaltrexoneNarcotic Antagonistsbuprenorphinenaltrexoneneonatal abstinence syndromeneonatal opioid withdrawal syndromeopioid use disorderpregnancyVivitrol

Identifiers

PMID31358302
PMCPMC7212240
OpenAlexW2965595222

What OpenQuestion holds

Textmetadata
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Registered trials

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.