Evidence map›Paper›PMID 25111040›Full record

Trial reportAmerican journal of perinatology2015

Randomized, controlled pilot trial of bupropion for pregnant smokers: challenges and future directions.

Angela L Stotts, Thomas F Northrup, Paul M Cinciripini, Jennifer A Minnix, Janice A Blalock, Patricia Dolan Mullen, Claudia Pedroza, Sean Blackwell

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in American journal of perinatology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 24% 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

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

  1. Pooled it
  2. Trial
  3. Placebo-controlled trial of bupropion for smoking cessation in pregnant women.American journal of obstetrics & gynecology MFM · 2021
    Trial
  4. Review
  5. Review
  6. Article
  7. Review
  8. Review
  9. 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 2 institutions in 1 country.

Angela L StottsUniversity of Texas Medical School at Houston, Houston, Texas.
Thomas F NorthrupUniversity of Texas Medical School at Houston, Houston, Texas.
Paul M CinciripiniUniversity of Texas Anderson Cancer Center, Houston, Texas.
Jennifer A MinnixUniversity of Texas Anderson Cancer Center, Houston, Texas.
Janice A BlalockUniversity of Texas Anderson Cancer Center, Houston, Texas.
Patricia Dolan MullenUniversity of Texas Medical School at Houston, Houston, Texas.
Claudia PedrozaUniversity of Texas Medical School at Houston, Houston, Texas.
Sean BlackwellUniversity of Texas Medical School at Houston, Houston, Texas.
The University of Texas MD Anderson Cancer Center · USThe University of Texas Health Science Center at Houston · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
U OF TEXAS HLTH SCI CTR HOUSTON CENTER FOR CLINICAL AND TRANSLATIONAL SCIENCESUL1RR024148 · NCRR · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI MCPHERSON, DAVID D · 2006 to 2010
$27.9M
NCI NIH HHS P30 CA016672NCRR NIH HHS UL1 RR 024148NCRR NIH HHS UL1 RR024148
6 · The paper itself

Abstract

objectiveThe aim of the study is to conduct an initial pilot trial evaluating the feasibility, safety, and efficacy of bupropion for smoking cessation in pregnancy. STUDY

designA randomized, double-blind, parallel-group pilot study of bupropion versus placebo with 50 pregnant smokers was planned. Eligibility criteria were restrictive (e.g., 14-26 weeks' gestation; no psychiatric conditions or medications) due to the unknown safety, tolerability, and side effect profile of bupropion in pregnancy. Bayesian analyses were planned to provide probability of benefit.

resultsSignificant challenges were encountered with regard to trial feasibility. Of 820 women screened, 112 were current smokers, but only 11 women were eligible and consented to participate in the study. Excluded women most often had a psychiatric disorder (23%); were outside the gestational range (14%); or declined to participate (11%).

conclusionsThis initial attempt to evaluate bupropion for smoking cessation during pregnancy will inform future trial methodology. Because of the unknown safety profile, conservative eligibility criteria were used and resulted in a large portion of this high-risk, low-income smoker population being excluded from the trial, raising questions regarding broad applicability, and highlighting the need to balance patient safety and trial feasibility. Large multisite studies will likely be needed to conduct definitive pharmacotherapy studies.

Indexed as

AdultBayes TheoremBupropionDouble-Blind MethodFemaleHumansPilot ProjectsPovertyPregnancySmokingSmoking CessationSurveys and QuestionnairesYoung AdultBupropion

Identifiers

PMID25111040
PMCPMC5937922
OpenAlexW2007476206

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.