Computerized Dosing of Teen Nicotine Gum Use

描述（由申请人提供）：我们建议开发一种手持式计算机 确定尼古丁口香糖使用的初始剂量和最终减量的计划 针对青少年的独特需求和吸烟模式， 吸烟者。该产品（NGDDD）将确定口香糖的初始剂量， 青少年吸烟者的基础上，他们的基线吸烟行为，然后提供一个 定期给药，分发和最终逐渐减少口香糖的使用，以促进 适当的初始尼古丁口香糖使用和减少滥用的可能性。以下 开发和试点测试，NGDDD将在为期6周的临床试验中进行评估。 对40名青少年吸烟者进行了试验。所有受试者将接受尼古丁口香糖， NGDDD原型设备将使用六周。受试者将访问 每周一次的诊所，以评估进展，口香糖的使用，副作用，并接受他们的 下周的尼古丁口香糖主要结果指标为 可行性研究将是最初的口香糖使用，与给药方案的依从性， 研究结束时的口香糖使用率和戒烟率。各种程序 还将评估使用变量，以指导第二阶段的修改。

DESCRIPTION (provided by applicant): We propose to develop a hand-held computer program to determine initial dosing and eventual tapering of nicotine gum use which targets and addresses the unique needs and smoking patterns of adolescent smokers. The product (NGDDD) will determine an initial dosing of gum use for adolescent smokers based on their baseline smoking behavior and then provide a scheduled dosing, dispensing and eventual gradual taper of gum use to promote appropriate initial nicotine gum use and minimize abuse liability. Following development and pilot testing, the NGDDD will be evaluated in a 6-week clinical trial with 40 teenage smokers. All subjects will receive nicotine gum and the NGDDD prototype device to use for a six-week period. Subjects will visit the clinic weekly to assess progress, gum use, side effects, and to receive their next week's supply of nicotine gum. The primary outcome measures for the feasibility study will be initial gum use, compliance with the dosing schedule, gum use at the end of the study and smoking cessation rates. Various program use variables also will be assessed to guide Phase II modifications.