Evidence map›Paper›PMID 39380562›Full record

Trial reportCPT: pharmacometrics & systems pharmacology2024

Physiologically based pharmacokinetic modeling of long-acting extended-release naltrexone in pregnant women with opioid use disorder.

Babajide Shenkoya, Mathangi Gopalakrishnan, Ahizechukwu C Eke

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in CPT: pharmacometrics & systems pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Trial
  2. Article
  3. Current approaches and advances in placental toxicology.Trends in endocrinology and metabolism: TEM · 2026
    Review
  4. Review
  5. Article
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

3 authors.

Babajide ShenkoyaDepartment of Pharmacy Practice, Center for Translational Medicine, University of Maryland School of Pharmacy, Baltimore, Maryland, USA.ORCID 0009-0005-3315-780X
Mathangi GopalakrishnanDepartment of Pharmacy Practice, Center for Translational Medicine, University of Maryland School of Pharmacy, Baltimore, Maryland, USA.ORCID 0000-0003-2881-9870
Ahizechukwu C EkeDivision of Maternal Fetal Medicine, Department of Gynecology & Obstetrics, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.ORCID 0000-0002-0070-9840

Funding

Integrated proteomic and metabolomic biomarker profiling for understanding metabolic syndrome in pregnant women living with HIV on Tenofovir Disoproxil Fumarate/Lamivudine/Dolutegravir (TLD)DP1HD115433 · NICHD · JOHNS HOPKINS UNIVERSITY · PI AHIZECHUKWU C. EKE · 2024 to 2026
$1.7M
Understanding Medication Adherence Benchmarks, Safety and Pharmacometrics of Novel Antiretrovirals in Pregnant Women Living with HIV.K23HD104517 · NICHD · JOHNS HOPKINS UNIVERSITY · PI EKE, AHIZECHUKWU C. · 2020 to 2024
$857k
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)National Institutes of Health (NIH) DP1HD115433National Institutes of Health (NIH) K23HD104517NICHD NIH HHS DP1 HD115433NICHD NIH HHS K23 HD104517
6 · The paper itself

Abstract

Opioid use disorders (OUD) are a major issue in the U.S. Current treatments for pregnant women, like methadone and buprenorphine require daily dosing and have adverse effects. Monthly injectable naltrexone (XR-NTX) mitigates these adverse effects but is not recommended during pregnancy due to limited pharmacokinetic and safety data. This study developed a physiologically based pharmacokinetic (PBPK) model to describe XR-NTX pharmacokinetics during pregnancy, and to predict dosing recommendations. Model predictions were successfully validated with observed data. Maternal plasma XR-NTX profiles were simulated for 400 non-pregnant virtual females at the approved dose of 380 mg, then randomized to continue with either 380, 285, 190, or 95 mg during pregnancy. The non-pregnant virtual females had a mean predicted C

Indexed as

Delayed-Action PreparationsModels, BiologicalNaltrexoneNarcotic AntagonistsOpioid-Related DisordersAdultArea Under CurveDose-Response Relationship, DrugFemaleHumansOpiate Substitution TreatmentPregnancyPregnancy ComplicationsYoung AdultDelayed-Action PreparationsNaltrexoneNarcotic Antagonists

Identifiers

PMID39380562
PMCPMC11578127

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.