COMBINING SCHEDULED REDUCTION WITH NICOTINE REPLACEMENT

将计划减少量与尼古丁替代相结合

• 批准号: 2895572
• 负责人: NEAL RICHARD BOYD
• 金额: $ 39.6万
• 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 2000-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2895572
• 关键词: behavior modification; behavioral /social science research tag; behavioral extinction; bioengineering /biomedical engineering; clinical research; clinical trials; computer assisted instruction; computer human interaction; computer program /software; computer system design /evaluation; drug withdrawal; handbook; human subject; human therapy evaluation; monitoring device; nicotine replacement; outcomes research; satisfaction; self help; smoking cessation

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.

描述：本项目第二阶段的总体目标是开发 一个容易管理的行为计划，作为一个伴侣， 尼古丁贴片用于戒烟。 项目名称：LifeSign 尼古丁贴片（LS-NP）将包括信用卡大小 计算机和程序指南。 计算机将通过改变 在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，提示使用者在固定时间吸烟 间隔，然后逐渐增加香烟之间的间隔， 从而减少吸烟。 计算机化吸烟时间表的目标 是双重的：减少尼古丁的摄入和破坏条件吸烟 在使用尼古丁贴片之前，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，并在临床上进行了测试。 研究对象94人。 取得了令人鼓舞的结果， 产品概念的可行性。 在第二阶段， 将开发生成系统，并随机临床结局 将进行为期六个月的随访研究，以评估 产品 吸烟者将被随机分配到以下两种情况之一： 贴剂加LS-NP或单独贴剂。 吸烟、贴剂使用、停药数据 症状，对计算机程序的依从性，以及 将收集满意度和可用性。 完成后 试用后，计划将制定一个版本的产品 适合商业发行。 拟定商业应用： 这种产品在近几年的市场中应该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FDA批准用于治疗糖尿病以来， 柜台销售。作为使用本发明的治疗辅助剂， 尼古丁贴片，本产品应具有显著的商业 可行性和积极的公共卫生影响。