Evidence map›Paper›PMID 21860340›Full record

Trial reportTherapeutic drug monitoring2011

Preliminary buprenorphine sublingual tablet pharmacokinetic data in plasma, oral fluid, and sweat during treatment of opioid-dependent pregnant women.

Marta Concheiro, Hendreé E Jones, Rolley E Johnson, Robin Choo, Marilyn A Huestis

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Therapeutic drug monitoring, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
4.4field-weighted citation impact, top 6% 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.

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

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 54 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Observational
  5. Review
  6. Article
  7. Article
  8. Opioid use disorder in pregnancy.The mental health clinician · 2019
    Article
  9. Article
  10. Review
  11. Pregnancy Increases Norbuprenorphine Clearance in Mice by Induction of Hepatic Glucuronidation.Drug metabolism and disposition: the biological fate of chemicals · 2018
    Article
  12. Article
  13. Article
  14. Article
  15. Review
  16. Review
  17. Article
  18. Article
  19. 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

5 authors at 4 institutions in 2 countries.

Marta ConcheiroServicio de Toxicología Forense, Instituto de Ciencias Forenses, Universidad de Santiago de Compostela, Spain.
Hendreé E Jones
Rolley E Johnson
Robin Choo
Marilyn A Huestis
Johns Hopkins Medicine · USNational Institute on Drug Abuse · USNational Institutes of Health · USReckitt Benckiser (United States) · US

Funding

Detection Of Drugs Of Abuse In Alternative Biological Fluids And TissuesZIADA000412 · NIDA · NATIONAL INSTITUTE ON DRUG ABUSE · PI SCHEIDWEILER, KARL · 2009 to 2016
$3.9M
Monitoring In Utero Drug ExposureZIADA000433 · NIDA · NATIONAL INSTITUTE ON DRUG ABUSE · PI SCHEIDWEILER, KARL · 2009 to 2016
$2.9M
METHADONE AND BUPRENORPHINE--ANTE AND POST PARTUMR01DA012220 · NIDA · JOHNS HOPKINS UNIVERSITY · PI JONES, HENDREE E. · 1999 to 2002
$1.7M
OPIATE AND NICOTINE DEPENDENCE--MEDICATIONS AND THERAPYK23DA000433 · NIDA · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI SULLIVAN, MARIA A · 1999 to 2003
$664k
Intramural NIH HHS ZIA DA000433NIDA NIH HHS K23 DA000433NIDA NIH HHS R01 DA012220NIDA NIH HHS R01 DA12220
6 · The paper itself

Abstract

backgroundBuprenorphine is currently under investigation as a pharmacotherapy to treat pregnant women for opioid dependence. This research evaluates buprenorphine (BUP), norbuprenophine (NBUP), buprenorphine-glucuronide (BUP-Gluc), and norbuprenorphine-glucuronide (NBUP-Gluc) pharmacokinetics after high-dose (14-20 mg) BUP sublingual tablet administration in three opioid-dependent pregnant women.

methodsOral fluid and sweat specimens were collected in addition to plasma specimens for 24 hours during gestation weeks 28 or 29 and 34, and 2 months after delivery. Time to maximum concentration was not affected by pregnancy; however, BUP and NBUP maximum concentration and area under the curve at 0 to 24 hours tended to be lower during pregnancy compared with postpartum levels.

resultsStatistically significant but weak positive correlations were found for BUP plasma and OF concentrations and BUP/NBUP ratios in plasma and oral fluid. Statistically significant negative correlations were observed for times of specimen collection and BUP and NBUP oral fluid/plasma ratios. BUP-Gluc and NBUP-Gluc were detected in only 5% of oral fluid specimens. In sweat, BUP and NBUP were detected in only four of 25 (12 or 24 hours) specimens in low concentrations (less than 2.4 ng/patch).

conclusionThese preliminary data describe BUP and metabolite pharmacokinetics in pregnant women and suggest that, like methadone, upward dose adjustments may be needed with advancing gestation.

Indexed as

Area Under CurveBuprenorphineDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansNarcotic AntagonistsOpioid-Related DisordersPostpartum PeriodPregnancySalivaSweatBuprenorphineNarcotic Antagonistsnorbuprenorphine

Identifiers

PMID21860340
PMCPMC3178674
OpenAlexW2062326432

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.