Oral Nicotine Replacement for Smoking Cessation

描述（由申请人提供）：本R21申请涉及美国过早死亡的主要可预防原因，吸烟。帮助吸烟者戒烟的最广泛使用的治疗方法是尼古丁替代疗法，但在六个月的时间里，它的成功率只有20%左右。基于尼古丁、感觉和习惯影响的吸烟行为模型，在两个试点项目中研究了调味饮料中的口服尼古丁递送，以建立尼古丁替代疗法的概念。本研究通过在戒烟试验中加入安慰剂对照组，进一步发展了口服尼古丁。该研究是一项两组、平行设计、安慰剂对照、随机临床试验。100名健康的成年志愿者将被随机分配接受尼古丁溶液（积极条件）或尼古丁溶液（控制条件）。受试者将被指示每小时将溶液添加到他们选择的饮料中，以满足吸烟的需要，持续6周。所有受试者将收到一份自助戒烟手册，以及简短的个人咨询。社区志愿者将通过报纸广告从当地大都市地区招募。纳入标准是：1)年龄在18-65岁之间；2)每天至少吸烟10支；3)有戒烟的愿望；4)愿意在登记后14天内设定“戒烟日期”。主要的排除标准是：1)任何需要监测的持续医疗问题2)处方药3)怀孕或哺乳。基线数据收集包括吸烟史、尼古丁依赖问卷、戒烟动机问卷。受试者将在戒烟日返回，治疗期间每周返回一次，共6周，然后每月返回一次，共6个月。在每次回访时，受试者将完成呼出一氧化碳测试，以及关于戒烟和溶液耐受性的问卷。主要结果是在戒烟后6个月持续戒烟。其他结果包括持续戒烟1个月和3个月，戒烟症状，治疗的副作用，治疗依从性和治疗溶液的感觉效果。本研究测试了一种有前景的新型尼古丁替代疗法与安慰剂的初步疗效。如果有效，对其安全性、有效性和机制的进一步研究将是有序的。

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.