COMBINING SCHEDULED REDUCTION WITH NICOTINE REPLACEMENT

描述：该项目的总体目标是开发一种自助辅助行为疗法，与尼古丁贴片(TNP)结合使用，用于戒烟。该计划将由两个部分组成：一台信用卡大小的手持电脑和一份行为治疗指南。该计算机将被用来构建一个预定的吸烟方案，为使用者开始使用TNP进行尼古丁替代疗法做准备。治疗指南将包含关于正确使用TNP的计算机信息的使用说明，以及一系列涉及促进戒烟和预防复发的标准行为策略的章节。这一第一阶段的项目将包括开发第一代原型系统和对80名吸烟者进行为期12周的可行性研究。吸烟者将被随机分配到两种情况之一：TNP与预定吸烟或标准TNP(与行为治疗手册)。可行性标准将是两组之间在吸烟复发潜伏期、贴片前阶段吸烟和尼古丁摄入量、戒断症状程度、吸烟冲动和行为应对策略的使用方面的统计上的显著差异；以及计算机计划组受试者在治疗期间尼古丁水平和对吸烟时间表的遵守程度的显著变化。试验数据和受试者的反馈将用于指导进一步的产品开发。在第二阶段，将开发第二代原型，并在大规模临床试验中进行评估。

DESCRIPTION: The overall goal of this project is to develop a self-help adjuvant behavioral treatment for use in conjunction with the transdermal nicotine patch (TNP) for smoking cessation. The program will be composed of two components: a credit-card sized hand-held computer and a behavioral treatment guide. The computer will be used to structure a scheduled smoking regimen that will prepare users for initiation of nicotine replacement therapy with the TNP. The treatment guide will contain instructions for use of the computer information on the appropriate use of TNP, and a series of chapters covering standard behavioral strategies to facilitate smoking cessation and relapse prevention. This Phase I project will include development of a first generation prototype system and a 12-week feasibility study with 80 smokers. Smokers will be randomly assigned to one of two conditions: TNP with scheduled smoking or standard TNP (with a behavioral treatment manual). Criteria for feasibility, will be statistically significant differences between groups on latency to smoking relapse; smoking and nicotine intake during the pre-patch phase; degree of withdrawal symptoms, urges to smoke, and use of behavioral coping strategies; and significant within treatment changes in nicotine levels and adherence to the smoking schedule among subjects in 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.