Evidence map›Paper›PMID 28669739›Full record

ArticleAmerican journal of obstetrics and gynecology2017

An evidence-based recommendation to increase the dosing frequency of buprenorphine during pregnancy.

Steve N Caritis, Jaime R Bastian, Hongfei Zhang, Hari Kalluri, Dennis English, Michael England, Stephanie Bobby, Raman Venkataramanan

Registry-linked trialOpen access · greenAbstract read
In one paragraph

Article in American journal of obstetrics and gynecology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03740243 (Comparison of Buprenorphine vs Buprenorphine/Naloxone on the Effects of Maternal Symptomatology), which is not on this map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 pooled it
5.2field-weighted citation impact, top 4% 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.

NCT03740243 phase4withdrawnnot on this mapstarted 2018, after this paper: background citation

Comparison of Buprenorphine vs Buprenorphine/Naloxone on the Effects of Maternal Symptomatology

TypeinterventionalSponsorStony Brook UniversityRan2018 to 2020Enrolled0ConditionsOpioid-use DisorderArmsBuprenorphine/naloxone, Buprenorphine
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 1 synthesis or guideline pooled it, 65 citations in OpenAlex.

  1. Guideline
  2. Hospital Care for Pregnant Persons With OUD Review.American journal of medicine open · 2025
    Review
  3. Article
  4. Article
  5. Article
  6. Review
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  12. Neonatal opioid withdrawal syndrome: a review of the science and a look toward the use of buprenorphine for affected infants.Journal of perinatology : official journal of the California Perinatal Association · 2022
    Review
  13. Article
  14. Article
  15. Article
  16. Review
  17. Article
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  19. Article
  20. Opioid use disorder in pregnancy.The mental health clinician · 2019
    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

8 authors at 1 institution in 1 country.

Steve N CaritisDivision of Maternal-Fetal Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA. Electronic address: scaritis@mail.magee.edu.
Jaime R BastianDepartment of Obstetrics, Gynecology, and Reproductive Sciences, School of Medicine, University of Pittsburgh, Pittsburgh, PA; Department of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, PA.
Hongfei ZhangDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, PA.
Hari KalluriDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, PA.
Dennis EnglishDepartment of Obstetrics, Gynecology, and Reproductive Sciences, School of Medicine, University of Pittsburgh, Pittsburgh, PA.
Michael EnglandDepartment of Obstetrics, Gynecology, and Reproductive Sciences, School of Medicine, University of Pittsburgh, Pittsburgh, PA.
Stephanie BobbyDepartment of Obstetrics, Gynecology, and Reproductive Sciences, School of Medicine, University of Pittsburgh, Pittsburgh, PA.
Raman VenkataramananDepartment of Pathology, School of Medicine, University of Pittsburgh, Pittsburgh, PA; Department of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, PA.
University of Pittsburgh · US

Funding

Pregnancy and Drug Metabolizing Enzymes and TransportersU10HD047905 · NICHD · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI CARITIS, STEVE N · 2004 to 2014
$9.7M
Optimization of Drug Dosing in Pregnant Women through Research and EducationU54HD047905 · NICHD · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI VENKATARAMANAN, RAMAN · 2015 to 2019
$3.7M
Training in Basic and Clinical Pharmacology in PregnancyT32HD071859 · NICHD · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI CARITIS, STEVE N, VENKATARAMANAN, RAMAN · 2012 to 2016
$722k
NICHD NIH HHS T32 HD071859NICHD NIH HHS U10 HD047905NICHD NIH HHS U54 HD047905
6 · The paper itself

Abstract

backgroundDose-adjusted plasma concentrations of buprenorphine are significantly decreased during pregnancy compared with the nonpregnant state. This observation suggests that pregnant women may need a higher dose of buprenorphine than nonpregnant individuals to maintain similar drug exposure (plasma concentrations over time after a dose). The current dosing recommendations for buprenorphine during pregnancy address the total daily dose of buprenorphine to be administered, but the frequency of dosing is not clearly addressed. Based on buprenorphine's long terminal half-life, once-daily or twice-daily dosing has generally been suggested.

objectiveThe objective of the study was to assess the impact of dosing frequency on buprenorphine plasma concentration time course during pregnancy. STUDY

designWe utilized 3 data sources to determine an optimal frequency for dosing of buprenorphine during pregnancy: data from a pharmacokinetic study of 14 pregnant and postpartum women on maintenance buprenorphine in a supervised clinical setting; data from pregnant women attending a buprenorphine clinic; and data from a physiologically based pharmacokinetic modeling of buprenorphine pharmacokinetics in nonpregnant subjects.

resultsAmong the 14 women participating in the pharmacokinetic study during and after pregnancy, plasma concentrations of buprenorphine were <1 ng/mL (the theoretical concentration required to prevent withdrawal symptoms) for 50-80% of the 12 hour dosing interval while at steady state. Among 62 women followed up in a opioid agonist treatment program, in which dosing frequency is determined in part by patient preference, 10 (16%) were on once-daily dosing, 10 (16%) were on twice-daily dosing, 28 (45%) were on thrice-daily dosing, and 14 (23%) were on four-times-daily dosing. A physiologically based pharmacokinetic model in nonpregnant subjects demonstrated that dosing frequency has an impact on the duration over which the plasma concentrations are below a specified plasma concentration threshold.

conclusionA more frequent dosing interval (ie, three-times-daily or four-times-daily dosing) may be required in pregnant women to sustain plasma concentrations above the threshold of 1 ng/mL to prevent withdrawal symptoms and to improve adherence.

Indexed as

Opiate Substitution TreatmentAdministration, SublingualAdultBuprenorphineDose-Response Relationship, DrugEvidence-Based PracticeFemaleHumansNarcotic AntagonistsOpioid-Related DisordersPregnancyPregnancy ComplicationsBuprenorphineNarcotic Antagonistsbuprenorphinedosing frequencypharmacokineticspregnancy

Identifiers

PMID28669739
PMCPMC5614874
OpenAlexW2729435930

What OpenQuestion holds

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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.