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
