COMPUTERIZED SCHEDULING OF NICOTINE GUM

尼古丁口香糖的计算机化调度

• 批准号: 2770112
• 负责人: ALBERT JEROME
• 金额: $ 30.25万
• 依托单位: PERSONAL IMPROVEMENT COMPUTER SYSTEMS
• 依托单位国家: 美国
• 财政年份: 1995
• 资助国家: 美国
• 起止时间: 1995-09-30 至 2000-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2770112
• 关键词: clinical research; clinical trials; computer program /software; computer system design /evaluation; human subject; human therapy evaluation; nicotine replacement; outcomes research; questionnaires; self help; smoking cessation

The overall goal of this project is to develop a computerized program for scheduling the use of nicotine gum. The program will work by first assessing a baseline smoking pattern and then prompting users when and how long to use nicotine gum. Across time, gum durations will be decreased and inter-gum intervals will be gradually increased until abstinence is achieved. The program will consist of a credit card size computer and a program guide. The product will be suitable as either an adjunct to extant smoking interventions or as a stand-alone product. This Phase I project will include development of a first generation prototype system and an 8-week feasibility study with 80 smokers. Smokers will be randomly assigned to one of two conditions: computer scheduled gum use or ad-lib gum use. Data on gum use, smoking, withdrawal symptoms, and ratings of satisfaction and usability will be collected. Criteria for feasibility will be: 1) statistically significant differences between groups for latency to smoking relapse, number of gums used, salivary cotinine levels, and degree of withdrawal symptoms; and 2) significant within treatment changes in cotinine levels and correlations between prescribed and actual gum use among 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. 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 gum are likely to increase dramatically if it is approved by the FDA for over the counter sale. As a treatment adjunct for the use of nicotine gum, this product should have both significant commercial viability and a significant public health impact.

该项目的总体目标是开发一个计算机化程序 安排尼古丁口香糖的使用。 该程序将首先运行 评估基线吸烟模式，然后提示用户何时以及如何 长期使用尼古丁口香糖。 随着时间的推移，口香糖的持续时间会减少 牙龈间隔将逐渐增加，直至戒断。 实现了。 该程序将由一台信用卡大小的计算机和一个 节目指南。 该产品适合作为辅助 现有的吸烟干预措施或作为独立产品。 该第一阶段项目将包括第一代产品的开发 原型系统以及对 80 名吸烟者进行的为期 8 周的可行性研究。 吸烟者 将被随机分配到以下两个条件之一：电脑预定口香糖 使用或随意使用口香糖。 有关口香糖使用、吸烟、戒断症状等的数据 将收集满意度和可用性的评级。 标准 可行性将是：1）统计上显着的差异 吸烟复发潜伏期、使用的牙龈数量、唾液的分组 可替宁水平和戒断症状程度； 2）显着 治疗期间可替宁水平的变化以及之间的相关性 计算机预定组中规定的和实际的口香糖使用情况。 数据 试验和受试者的反馈将用于进一步指导 产品开发。 在第二阶段，第二代原型机将 在大规模临床试验中进行开发和评估。 拟议的商业应用：该产品应具有广泛的 对近四分之一的美国成年人具有商业吸引力 吸烟的人口。 尼古丁口香糖的销量可能会增加 如果 FDA 批准其在柜台销售，则效果会显着提高。 作为 作为使用尼古丁口香糖的治疗辅助剂，该产品应具有 既具有重要的商业可行性，又具有重要的公共卫生意义 影响。