COMBINING SCHEDULED REDUCTION WITH NICOTINE REPLACEMENT

产品说明：该项目的总体目标是开发一种易于管理的行为计划，作为使用尼古丁贴片戒烟的伴侣。 该计划，生命标志尼古丁贴片（LS-NP），将包括一个信用卡大小的计算机和程序指南。 在使用尼古丁贴片之前，电脑将通过改变吸烟习惯来工作。 计算机将评估基线吸烟模式，提示使用者在固定的时间间隔吸烟，然后逐渐增加吸烟间隔，从而减少吸烟。 计算机化吸烟时间表的目标有两个：在使用尼古丁贴片之前减少尼古丁摄入量并破坏条件性吸烟模式。 该产品将适合作为自助程序或用于临床治疗环境。 在第一阶段，开发了一个原型系统，并在94名受试者的临床研究中进行了测试。 取得了可喜的成果，证明了产品概念的可行性。 在第二阶段，将开发第二代系统，并将进行为期6个月的随机临床结局研究，以评估产品。吸烟者将被随机分配到两个条件之一：贴剂加LS-NP或贴剂单独。 将收集关于吸烟贴片使用、戒断症状、计算机程序依从性以及满意度和可用性评级的数据。 试验完成后，将制定适合商业发布的产品版本计划。

DESCRIPTION: The overall goal of this 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.