COMPUTERIZED SCHEDULING OF NICOTINE GUM

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The overall goal of this project is to develop a computerized program for scheduling the use of nicotine gum. The program will work by first assessing a baseline smoking pattern and then prompting users when and how long to use nicotine gum. Across time, gum durations will be decreased and inter-gum intervals will be gradually increased until abstinence is achieved. The program will consist of a credit card size computer and a program guide. The product will be suitable as either an adjunct to extant smoking interventions or as a stand-alone product. This Phase I project will include development of a first generation prototype system and an 8-week feasibility study with 80 smokers. Smokers will be randomly assigned to one of two conditions: computer scheduled gum use or ad-lib gum use. Data on gum use, smoking, withdrawal symptoms, and ratings of satisfaction and usability will be collected. Criteria for feasibility will be: 1) statistically significant differences between groups for latency to smoking relapse, number of gums used, salivary cotinine levels, and degree of withdrawal symptoms; and 2) significant within treatment changes in cotinine levels and correlations between prescribed and actual gum use among the computer scheduled group. Data from the trial and feedback from subjects will be used to guide further product development. During Phase II, a second generation prototype will be developed and evaluated in a large-scale clinical trial. PROPOSED COMMERCIAL APPLICATION: This product should have broad commercial appeal among the nearly one quarter of the U.S. adult population that smokes. Sales of nicotine gum are likely to increase dramatically if it is approved by the FDA for over the counter sale. As a treatment adjunct for the use of nicotine gum, this product should have both significant commercial viability and a significant public health impact.