Evidence map›Paper›PMID 23106924›Full record

Trial reportAddiction (Abingdon, England)2012

Maternal Opioid Treatment: Human Experimental Research (MOTHER)--approach, issues and lessons learned.

Hendrée E Jones, Gabriele Fischer, Sarah H Heil, Karol Kaltenbach, Peter R Martin, Mara G Coyle, Peter Selby, Susan M Stine, Kevin E O'Grady, Amelia M Arria

Abstract readMulticenter StudyRandomized Controlled TrialReview
In one paragraph

Trial report in Addiction (Abingdon, England), 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 1 pooled it
–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

35 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Maintenance agonist treatments for opiate-dependent pregnant women.The Cochrane database of systematic reviews · 2020
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  18. Adverse neonatal outcomes associated with maternal severe mental health diagnoses and opioid use.Journal of perinatology : official journal of the California Perinatal Association · 2020
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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

10 authors.

Hendrée E JonesDepartment of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA. hjones18@jhmi.edu
Gabriele Fischer
Sarah H Heil
Karol Kaltenbach
Peter R Martin
Mara G Coyle
Peter Selby
Susan M Stine
Kevin E O'Grady
Amelia M Arria

Funding

YOHIMBINE AS A MODEL OF ORTHOSTATIC INTOLERANCEM01RR000095 · NCRR · VANDERBILT UNIVERSITY · PI MAY, JAMES M. · 1985 to 2008
$38.3M
WEIGHT MAINTENANCE AND PSYCHOLOGICAL BENEFITS OF EXERCISEM01RR000109 · NCRR · UNIVERSITY OF VERMONT &ST AGRIC COLLEGE · PI KIRKPATRICK, BETH DIANE · 1985 to 2010
$24.3M
Maternal Opioid Treatment: Human Experimental ResearchR01DA015764 · NIDA · JOHNS HOPKINS UNIVERSITY · PI JONES, HENDREE E · 2004 to 2008
$5.8M
Maternal Opioid Treatment: Human Experimental ResearchR01DA015738 · NIDA · THOMAS JEFFERSON UNIVERSITY · PI KALTENBACH, KAROL A · 2004 to 2008
$3.6M
Maternal Opioid Treatment: Human Experimental ResearchR01DA015713 · NIDA · VANDERBILT UNIVERSITY · PI MARTIN, PETER ROBERT · 2004 to 2008
$2.5M
Maternal Opioid Treatment: Human Experimental ResearchR01DA015832 · NIDA · WAYNE STATE UNIVERSITY · PI STINE, SUSAN M · 2004 to 2009
$2.2M
Maternal Opioid Treatment: Human Experimental ResearchR01DA018410 · NIDA · UNIVERSITY OF VERMONT &ST AGRIC COLLEGE · PI HEIL, SARAH H · 2004 to 2008
$2.2M
Maternal Opioid Treatment: Human ExperimentalR01DA018417 · NIDA · MEDICAL UNIVERSITY OF VIENNA · PI FISCHER, GABRIELE · 2004 to 2008
$1.8M
Maternal Opioid Treatment: Human Experimental ResearchR01DA015778 · NIDA · WOMEN AND INFANTS HOSPITAL-RHODE ISLAND · PI LESTER, BARRY M. · 2004 to 2009
$1.6M
Maternal Opioid Treatment: Human Experimental ResearchR01DA015741 · NIDA · ST. JOSEPH'S HEALTH CENTRE · PI SELBY, PETER L · 2004 to 2008
$643k
NCRR NIH HHS M01 RR000095NCRR NIH HHS M01 RR000109NCRR NIH HHS M01 RR 00095NCRR NIH HHS M01 RR 109NIDA NIH HHS R01 DA015713NIDA NIH HHS R01 DA 015738NIDA NIH HHS R01 DA015738NIDA NIH HHS R01 DA 015741NIDA NIH HHS R01 DA015741NIDA NIH HHS R01 DA 015764NIDA NIH HHS R01 DA015764NIDA NIH HHS R01 DA 015778NIDA NIH HHS R01 DA015778NIDA NIH HHS R01 DA015832NIDA NIH HHS R01 DA 017513NIDA NIH HHS R01 DA 018410NIDA NIH HHS R01 DA018410NIDA NIH HHS R01 DA 018417NIDA NIH HHS R01 DA018417NIDA NIH HHS R01 DA 15832
6 · The paper itself

Abstract

aimsThe Maternal Opioid Treatment: Human Experimental Research (MOTHER) project, an eight-site randomized, double-blind, double-dummy, flexible-dosing, parallel-group clinical trial is described. This study is the most current--and single most comprehensive--research effort to investigate the safety and efficacy of maternal and prenatal exposure to methadone and buprenorphine.

methodsThe MOTHER study design is outlined, and its basic features are presented.

conclusionsAt least seven important lessons have been learned from the MOTHER study: (i) an interdisciplinary focus improves the design and methods of a randomized clinical trial; (ii) multiple sites in a clinical trial present continuing challenges to the investigative team due to variations in recruitment, patient populations and hospital practices that, in turn, differentially impact recruitment rates, treatment compliance and attrition; (iii) study design and protocols must be flexible in order to meet the unforeseen demands of both research and clinical management; (iv) staff turnover needs to be addressed with a proactive focus on both hiring and training; (v) the implementation of a protocol for the treatment of a particular disorder may identify important ancillary clinical issues worthy of investigation; (vi) timely tracking of data in a multi-site trial is both demanding and unforgiving; and (vii) complex multi-site trials pose unanticipated challenges that complicate the choice of statistical methods, thereby placing added demands on investigators to effectively communicate their results.

Indexed as

Opiate Substitution TreatmentBuprenorphineDouble-Blind MethodDrug Administration ScheduleFemaleHumansInfant, NewbornNarcotic AntagonistsNeonatal Abstinence SyndromeOpioid-Related DisordersPatient SelectionPregnancyPregnancy ComplicationsRandomized Controlled Trials as TopicTreatment OutcomeUnited StatesBuprenorphineNarcotic Antagonists

Identifiers

PMID23106924
PMCPMC4497510

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.