Oral Nicotine Replacement for Smoking Cessation

口服尼古丁替代品戒烟

• 批准号: 6675871
• 负责人: ERIC C WESTMAN
• 金额: $ 15.4万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-30 至 2006-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6675871
• 关键词: adolescence (12-20); adult human (21+); behavioral /social science research tag; blood pressure; body weight; breath composition; breath tests; clinical research; clinical trials; craving; dosage; drug abuse chemotherapy; drug addiction; drug adverse effect; drug withdrawal; human subject; human therapy evaluation; motivation; nicotine; nicotine replacement; oral administration; patient oriented research; questionnaires; satiations; smoking cessation; taste; tobacco abuse

DESCRIPTION (provided by applicant): This R21 application addresses the leading preventable cause of premature death in the United States, cigarette smoking. The most widely used treatment to help smokers quit is nicotine replacement therapy, but its success rates are only about 20% at six months. Based on a model of the smoking behavior involving nicotine, sensory, and habit effects, oral nicotine delivery in flavored beverages has been studied in two pilot projects to build on the concept of nicotine replacement therapy. This study continues the development of oral nicotine further by adding a placebo control group in a smoking cessation trial. The study is a two-group, parallel-design, placebo-controlled, randomized clinical trial. One-hundred healthy adult volunteers motivated to quit smoking will be randomized to receive either nicotine solution (active condition) or Iobeline solution (control condition). Subjects will be instructed to add the solution to the beverages of their choice every hour as needed for smoking urges for 6 weeks. All subjects will receive a self-help cessation manual, and brief individual counseling. Community volunteers will be recruited from the local metropolitan area by newspaper advertisements. Inclusion criteria are: 1) age from 18-65 years 2) smoking at least 10 cigarettes per day 3) desire to quit smoking 4) willingness to set a "quit date" within 14 days of enrollment. Major exclusion criteria are: 1) any ongoing medical problem requiring monitoring 2) prescription medication 3) pregnancy or breastfeeding. Baseline data collection includes smoking history, nicotine dependence questionnaire, smoking withdrawal and motivation questionnaires. Subjects will return on the quit date, every week for 6 weeks during treatment, then every month for 6 months. At each return visit subjects will complete an exhaled carbon monoxide test, and questionnaires regarding smoking withdrawal and solution tolerability. The primary outcome is continuous smoking abstinence 6 months after the quit date. Other outcomes include continuous smoking abstinence at 1 and 3 months, smoking withdrawal symptoms, side effects of treatment, treatment compliance, and sensory effects of treatment solutions. This study tests the preliminary efficacy of a promising novel nicotine replacement therapy compared to placebo. If efficacious, further research into its safety, efficacy, and mechanisms will be in order.

描述（由申请人提供）：此R21申请涉及美国早期死亡的主要预防原因，即吸烟。尼古丁替代疗法是最广泛使用的治疗方法是尼古丁替代疗法，但其成功率在六个月时仅约20％。基于涉及尼古丁，感觉和习惯效应的吸烟行为模型，已经在两个试点项目中研究了口服尼古丁饮料中的尼古丁递送，以基于尼古丁替代疗法的概念。这项研究通过在戒烟试验中添加安慰剂对照组进一步发展了口服尼古丁的发展。 该研究是一项两组平行设计的，安慰剂对照的，随机的临床试验。一百个健康的成年志愿者戒烟动机将被随机分配，以接收尼古丁溶液（活动状况）或Iobeline解决方案（控制状况）。将指示受试者在每小时需要吸烟6周的情况下，每小时为他们选择的饮料添加解决方案。所有受试者都将获得自助戒烟手册和简短的个人咨询。社区志愿者将通过报纸广告从当地的大都市地区招募。纳入标准为：1）年龄从18 - 65年开始2）每天至少吸烟3）渴望戒烟的愿望4）愿意在入学后14天内设定“退出日期”。主要的排除标准是：1）需要监测的任何正在进行的医疗问题2）处方药3）怀孕或母乳喂养。 基线数据收集包括吸烟史，尼古丁依赖问卷，抽烟和动机问卷。受试者将在退出日期，每周持续6周，然后每月持续6个月。在每个回访时，受试者将完成呼出的一氧化碳测试，以及有关戒烟和溶液耐受性的问卷。主要结果是退出日期6个月后连续戒烟。其他结果包括在1和3个月的持续戒烟，吸烟戒断症状，​​治疗的副作用，治疗依从性以及治疗溶液的感觉影响。 这项研究测试了与安慰剂相比，有希望的新型尼古丁替代疗法的初步疗效。如果有效，将进一步研究其安全性，功效和机制。