Nicotine replacement for the treatment of smoking dependence has become a popular yet controversial form of treatment There are many ways in which nicotine can be administered, thus allowing for more options for individualized treatment. However, one of the controversies regarding nicotine replacement is whether it is efficacious by itself or only in the context of a behavioral treatment program. In addition, there is concern that some of those who use nicotine replacement will become dependent on that form of nicotine. Unfortunately, few studies have assessed the efficacy and long term use of nicotine replacement treatments in the context of a very minimal behavioral treatment program, and even fewer have evaluated the dependence potential of nicotine replacement products. The proposed studies were designed to assess the safety and efficacy of nicotine patch and gum in a truly self-help program. No recommendations about smoking cessation will he provided to subjects. The first two proposed studies are randomized, double-blind, placebo- controlled clinical trials designed to separately assess (1) the likelihood that nicotine gum and patch will be used for longer periods than recommended (regardless of smoking status) and (2) the efficacy of nicotine gum and patch as aids to smoking cessation in a self-help protocol. Treatment conditions in the first two studies are as follows: Study #1: 15 mg nicotine or placebo transdermal patch, and Study #2: 4 mg, 2 mg, or placebo gum. The second two studies are randomized clinical trials designed to separately evaluate (1) the effect of nicotine patch and gum cost on medication use, (2) the likelihood that these products will be used for longer periods than recommended, and (3) the abstinence rates of 4 mg nicotine gum and 15 mg nicotine patch (3Ocm2) as a function of medication cost Treatment conditions in the second two studies are as follows: Study # 3:15 mg nicotine patch at full price ($5O/box of 14), half price ($25/box), or at no cost, and Study #4: 4 mg nicotine gum at full price ($66/box of 96 pieces), half price ($33/box), or at no cost. The results of the proposed studies can lead to a better understanding of the efficacy of nicotine replacement products when minimal behavioral treatment is provided and when costs are varied. The results could also contribute to decision-making regarding the potential switch to over-the- counter medication status.
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