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Am J Perinatol 2015; 32(04): 351-356
DOI: 10.1055/s-0034-1386635
Original Article
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Randomized, Controlled Pilot Trial of Bupropion for Pregnant Smokers: Challenges and Future Directions

Angela L. Stotts
1   University of Texas Medical School at Houston, Houston, Texas
,
Thomas F. Northrup
1   University of Texas Medical School at Houston, Houston, Texas
,
Paul M. Cinciripini
2   University of Texas Anderson Cancer Center, Houston, Texas
,
Jennifer A. Minnix
2   University of Texas Anderson Cancer Center, Houston, Texas
,
Janice A. Blalock
2   University of Texas Anderson Cancer Center, Houston, Texas
,
Patricia Dolan Mullen
1   University of Texas Medical School at Houston, Houston, Texas
3   University of Texas School of Public Health, Houston, Texas
,
Claudia Pedroza
1   University of Texas Medical School at Houston, Houston, Texas
,
Sean Blackwell
1   University of Texas Medical School at Houston, Houston, Texas
› Author Affiliations
Further Information

Publication History

18 April 2014

13 June 2014

Publication Date:
11 August 2014 (online)

Also available at
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Abstract

Objective The 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 Design A 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.

Results Significant 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%).

Conclusions This 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.

Keywords

pregnancy - smoking - bupropion - pharmacotherapy - smoking cessation
 

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