COMPUTERIZED SCHEDULING OF NICOTINE INHALER USE

描述：这个项目的总体目标是开发一个计算机化的程序，用于安排尼古丁吸入器的使用。该计划将由一台信用卡大小的计算机和一份节目指南组成。计算机将首先评估基线吸烟率，然后将基线吸烟率转换为吸入器调度算法。计算机将提示用户何时以及多长时间吸上吸入器。在最初的固定剂量后，吸入器之间的间隔将逐渐增加，直到实现戒断。该产品将适合用于个人或基于群体的治疗。这一第一阶段项目将包括开发第一代原型系统和为期12周的100名吸烟者的可行性研究。吸烟者将被随机分配到两种情况中的一种：使用电脑预定吸入器或使用即兴吸入器。将收集有关吸入器使用、吸烟、戒断症状以及满意度和可用性评级的数据。可行性的标准将是在治疗的第一周内，吸烟复发的潜伏期和每天吸入器的次数在组间的统计学上的显着差异。研究数据和受试者的反馈将被用来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 computerized program for scheduling the use of nicotine inhalers. The program will consist of a credit card size computer and a program guide. The computer will work by first assessing a baseline smoking rate then translating baseline rate into an inhaler scheduling algorithm. The computer will prompt users when and how long to puff on inhalers. After an initial fixed-dosing period, intervals between inhaler will be increased gradually until abstinence is achieved. The product will be suitable for use in either individual or group-based treatment. This Phase I project will include development of a first generation prototype system and a 12-week feasibility study with 100 smokers. Smokers will be randomly assigned to one of two conditions: computer scheduled inhaler use or ad lib inhaler use. Data on inhaler use, smoking, withdrawal symptoms, and ratings of satisfaction and usability will be collected. Criteria for feasibility will be statistically significant differences between groups for latency to smoking relapse and number of inhaler sessions per day during the first week of treatment. Data from the study 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.