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

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.