COMBINING SCHEDULED REDUCTION WITH NICOTINE REPLACEMENT

描述：第二阶段项目的总体目标是开发 一个易于管理的行为计划，可作为 使用尼古丁贴片戒烟。 该计划，生命标志 对于尼古丁贴片 (LS-NP)，将包含信用卡大小 计算机和节目指南。 计算机将通过改变来工作 使用尼古丁贴片之前的吸烟习惯。 计算机将 评估基线吸烟模式，提示用户在固定时间吸烟 吸烟的间隔，然后逐渐增加吸烟的间隔， 从而减少吸烟。 电脑化吸烟时间表的目标 是双重的：减少尼古丁摄入量并破坏条件吸烟 使用尼古丁贴片之前的模式。该产品将适合 作为自助计划或用于临床治疗环境。 在第一阶段，开发了原型系统并进行了临床测试 学习 94 个科目。 取得了有希望的结果，证明 产品概念的可行性。 在第二阶段，第二个 将开发生成系统，并随机化临床结果 将进行六个月随访的研究来评估 产品。 吸烟者将被随机分配到以下两种情况之一： 补丁加 LS-NP 或单独补丁。 有关吸烟、贴剂使用、戒断的数据 症状、对计算机程序的遵守情况以及评级 将收集满意度和可用性。 完成后 试用后，将制定产品版本计划 适合商业发布。 拟议的商业应用： 该产品应在近一类产品中具有广泛的商业吸引力 四分之一的美国成年人吸烟。尼古丁销售 自从获得 FDA 批准以来，补丁数量急剧增加 柜台销售。作为使用的治疗辅助剂 尼古丁贴片，该产品应具有显着的商业价值 可行性和积极的公共卫生影响。

DESCRIPTION: The overall goal of this Phase II project is to develop an easily administered behavioral program to serve as a companion to the use of the nicotine patch for smoking cessation. The program, LifeSign for the Nicotine Patch (LS-NP), will consist of a credit card size computer and a program guide. The computer will work by altering smoking habits prior to use of the nicotine patch. The computer will assess baseline smoking patterns, prompt users to smoke at fixed intervals, and then gradually increase intervals between cigarettes, thereby reducing smoking. The goal of the computerized smoking schedule is twofold: decrease nicotine intake and disrupt conditioned smoking patterns prior to using the nicotine patch. The product will be suitable as either a self-help program or for use in clinical treatment settings. During Phase I, a prototype system was developed and tested in clinical study with 94 subjects. Promising results were obtained demonstrating the feasibility of the product concept. During Phase II, a second generation system will be developed, and a randomized clinical outcome study with six-month follow-up will be conducted to evaluate the product. Smokers will be randomly assigned to one of two conditions: patch plus LS-NP or patch alone. Data on smoking, patch use, withdrawal symptoms, compliance with the computerized program, and ratings of satisfaction and usability will be collected. Following completion of the trial, plans will be formulated for a version of the product appropriate for commercial release. 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 patches have increased dramatically since it was approved by the FDA for over the counter sales. As a treatment adjunct for the use of the nicotine patch, this product should have both significant commercial viability and a positive public health impact.