Double-blind, Placebo-Controlled Pilot Study of Bupropion to Promote Smoking Cessation During Pregnancy
A randomized, double-blind, parallel group design will be used to allow a rigorous
preliminary assessment of the feasibility, effectiveness, and safety of bupropion SR
(sustained release; packaged as Zyban by GlaxoSmithKline) in promoting smoking cessation
among women in their second and third trimester of pregnancy. Fifty pregnant smokers will be
randomized to receive an 8-week course of either bupropion SR or matching placebo tablets.
Both groups will receive evidence-based smoking cessation counseling. The primary smoking
outcome will be 7-day point prevalence abstinence with cotinine validation at the end of the
treatment. Secondary outcomes include enrollment, retention, and compliance rates;
continuous abstinence from end of treatment through the 2 week followup; continuous
abstinence from birth to 2nd week postpartum followup; self-reported reduction in number of
cigarettes smoked per day; and maternal side effects and perinatal/neonatal outcomes.
Preliminary smoking cessation and safety outcomes will be assessed for the generation of
evidence-based hypotheses regarding clinical benefit of bupropion for pregnant smokers in
preparation fo a larger trial.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
7-day point prevalence smoking abstinence with cotinine validation at the end of treatment
1 week post treatment
Angela L Stotts, PhD
The University of Texas Health Science Center, Houston
United States: Food and Drug Administration
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