) The overall goals of this smoking cessation research are: 1) to understand the factors causing relapse to cigarettes, and 2) to design and evaluate treatments based on that understanding. In a 2 X 2 factorial design, where all subjects are receiving nicotine gum, the proposed research will test a series of hypotheses about the clinical efficacy, the cost, and the cost effectiveness of brief versus extended treatment, and of medical management alone versus medical management plus psychosocial support. In the brief treatment conditions, subjects will be treated for three months. In the extended treatment conditions, subjects will be treated for one year, which will include year long access to nicotine gum. This study has three interrelated foci: The first is to determine the relative efficacy of brief versus extended treatment in assisting smoking cessation; the second is to determine the relative efficacy of the two levels of psychosocial intervention (medical management alone vs. medical management plus psychosocial support) in assisting smoking cessation; and the third is to compare the cost and the cost effectiveness of these treatments. A total of 360 nicotine dependent individuals who are applying for smoking cessation treatment will be stratified by number of cigarettes smoked, past treatment failure using nicotine replacement therapy versus not, and on history of depression versus not, and randondy assigned from the stratified blocks to receive one of the four treatment conditions. A complete instrument battery will be done at baseline (Week 0); further assessments will be completed at brief treatment termination (Week 12), 6 months (Week 24), 9 months (Week 36), and one year (Week 52). Variables assessed are smoking behavior and biochemically verified smoking status, diagnosis, demographics and treatment history, state and trait measures of mood, support for quitting smoking, cigarette craving, and medication side effects. The cost effectiveness of the treatment conditions will be determined. If funded, this study will provide data about the efficacy and the cost effectiveness of treatments for smoking cessation based on rigorously designed clinical experiments. These data have implications for treatment providers and policy makers.
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