Computerized Dosing of Teen Nicotine Gum Use

青少年尼古丁口香糖使用的计算机剂量

• 批准号: 6486322
• 负责人: WILLIAM T. RILEY
• 金额: $ 17.5万
• 依托单位: PERSONAL IMPROVEMENT COMPUTER SYSTEMS
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-15 至 2004-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6486322
• 关键词: adolescence (12-20); clinical research; clinical trials; computer assisted patient care; computer program /software; computer system design /evaluation; dosage; drug screening /evaluation; human subject; human therapy evaluation; nicotine replacement; patient oriented research; smoking cessation; substance abuse related behavior; tobacco abuse; tobacco abuse prevention

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.

描述（由申请人提供）：我们建议开发一款手持式计算机 确定初始剂量和最终逐渐减少尼古丁口香糖使用的计划 针对并解决青少年的独特需求和吸烟模式 吸烟者。该产品（NGDDD）将确定口香糖使用的初始剂量 青少年吸烟者根据他们的基线吸烟行为，然后提供 预定的剂量、分配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并最大限度地减少滥用可能性。下列的 开发和试点测试，NGDDD 将在为期 6 周的临床中进行评估 对 40 名青少年吸烟者进行的试验。所有受试者都将接受尼古丁口香糖和 NGDDD 原型设备使用六周。受试者将参观 每周一次的诊所评估进展、口香糖的使用、副作用，并接受他们的指导 下周的尼古丁口香糖供应情况。主要结果指标 可行性研究将是口香糖的初始使用、遵守剂量时间表、 研究结束时口香糖的使用情况和戒烟率。各种节目 使用变量也将被评估以指导第二阶段的修改。