SCHEDULED, GRADUAL REDUCTION FOR PREGNANT SMOKERS

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Smoking during pregnancy is associated with increased risk for the fetus, newborn infant, and mother. Self-help smoking cessation programs may be ideally suited for pregnant smokers given that most smokers prefer to quit on their own, group-based models of smoking cessation have limited appeal to pregnant smokers, and pharmacological methods (nicotine replacement, buproprion) are generally contraindicated during pregnancy. In this Phase l project, we propose to develop and evaluate a self-help smoking cessation program for pregnant smokers using the technology and methods of computer-based, scheduled graduation reduction (SGR) originally pioneered by our research group. The program will consist of two components: (l) an easy to use, credit-card sized LifeSign computer which implements a SGR protocol; and (2) a Program Guide tailored to the unique interests and issues of pregnant smokers. During Phase I, a prototype of the LifeSign Program for Pregnant Smokers will be evaluated in a 10-week feasibility study with N=100 subjects randomly assigned to one of two conditions: (l) LifeSign; or (2) minimal contact self-help control. The primary outcome measures of interest include biologically- verified abstinence rates at 10-week follow-up and reductions from baseline in smoking rate and carbon monoxide levels. Feasibility will be evaluated on the basis of treatment and process outcomes and measures of user satisfaction. During Phase II, a second generation prototype of the program will be developed and evaluated in a larger scale clinical trial. Overall, this project will allow for the development and evaluation of a novel self-help smoking cessation intervention for pregnant smokers, a target population in need of expanded smoking cessation treatment options. PROPOSED COMMERCIAL APPLICATIONS: Despite the risks of smoking, recent data indicate that up to 14% of pregnant women smoke during pregnancy. This project will evaluate an important self-help smoking cessation approach for pregnant smokers using computer-based scheduled gradual reduction. The proposed product will offer an easy to use treatment option for pregnant smokers and may have broad utility as an effective public health tool.