COMPUTERIZED SCHEDULING OF NICOTINE GUM

这个项目的总体目标是开发一个计算机化的程序，用于 安排尼古丁口香糖的使用。这项计划将首先奏效 评估基线吸烟模式，然后提示用户何时和如何吸烟 渴望使用尼古丁口香糖。随着时间的推移，口香糖的持续时间将会减少 口香糖间隔时间将逐渐增加，直到禁欲 已实现。该计划将由一台信用卡大小的计算机和一台 节目指南。该产品将适合作为以下任一种辅助产品 现有的吸烟干预措施或作为独立产品。 这个第一阶段的项目将包括第一代的开发 原型系统和对80名吸烟者进行的为期8周的可行性研究。吸烟者 将被随机分配到以下两种情况之一：计算机计划口香糖 使用或临时使用口香糖。关于口香糖使用、吸烟、戒断症状和 满意度和易用性的评分将被收集。标准 可行性将是：1)在统计上有显著差异 吸烟复发潜伏期、使用口香糖的数量、唾液的分组 可替宁水平和戒断症状的程度；以及2)显著 治疗期间可替宁水平的变化及其相互关系 计算机计划组中的处方和实际口香糖使用情况。数据 受试者的反馈将被用来进一步指导 产品开发。在第二阶段，第二代原型将 将在大规模临床试验中开发和评估。 建议的商业应用：本产品应具有广泛的 在近四分之一的美国成年人中具有商业吸引力 吸烟的人口。尼古丁口香糖的销量可能会增加 如果FDA批准它在场外销售，这将是戏剧性的。AS 作为尼古丁口香糖的治疗辅助剂，本产品应具有 既有重大的商业可行性，又有重大的公共卫生 冲击力。

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.