COMBINING SCHEDULED REDUCTION WITH NICOTINE REPLACEMENT

将计划减少量与尼古丁替代相结合

• 批准号: 2009972
• 负责人: ALBERT JEROME
• 金额: $ 9.98万
• 依托单位: PERSONAL IMPROVEMENT COMPUTER SYSTEMS
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-05-01 至 1997-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2009972
• 关键词: behavior modification; behavioral /social science research tag; behavioral extinction; clinical research; computer assisted instruction; computer human interaction; computer program /software; computer system design /evaluation; data collection methodology /evaluation; handbook; human subject; method development; nicotine; outcomes research; self help; smoking cessation; transdermal drug delivery

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.

描述：该项目的总体目标是开发一种自助辅助行为治疗方法，与透皮尼古丁贴片 (TNP) 结合使用来戒烟。 该程序将由两部分组成：信用卡大小的手持电脑和行为治疗指南。 该计算机将用于构建预定的吸烟方案，为用户开始使用 TNP 尼古丁替代疗法做好准备。 治疗指南将包含有关正确使用 TNP 的计算机信息的使用说明，以及涵盖促进戒烟和预防复吸的标准行为策略的一系列章节。 该第一阶段项目将包括开发第一代原型系统以及对 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以下两种情况之一：计划吸烟的 TNP 或标准 TNP（带有行为治疗手册）。 可行性标准是各组之间在吸烟复发潜伏期方面存在统计学上的显着差异；贴片前阶段吸烟和尼古丁摄入量；戒断症状、吸烟冲动以及行为应对策略的使用程度；计算机计划组中的受试者的尼古丁水平和吸烟计划依从性在治疗过程中发生了显着变化。 试验数据和受试者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。