Oral Nicotine Replacement for Smoking Cessation

描述(由申请人提供)：这份R21申请针对的是在美国导致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的治疗方法是尼古丁替代疗法，但其6个月的成功率仅为20%左右。基于一个涉及尼古丁、感官和习惯影响的吸烟行为模型，我们在两个试点项目中研究了加味饮料中尼古丁的口服传递，以建立尼古丁替代疗法的概念。这项研究通过在戒烟试验中增加一组安慰剂对照组来进一步发展口服尼古丁。该研究是一项两组、平行设计、安慰剂对照、随机的临床试验。100名有戒烟动机的健康成年志愿者将随机接受尼古丁溶液(活动条件)或碘比林溶液(对照条件)。受试者将被指示每小时向他们选择的饮料中添加所需的溶液，以满足吸烟的需要，为期6周。所有受试者都将收到一份自助戒烟手册，并简要介绍个人咨询。社区志愿者将通过报纸广告从当地大都市地区招募。纳入的标准是：1)18-65岁2)每天至少抽10支烟3)希望戒烟4)愿意在注册后14天内设定“戒烟日期”。主要的排除标准是：1)任何持续的需要监测的医疗问题；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、戒烟和动机问卷。受试者将在戒烟日返回，在治疗期间每周返回一次，持续6周，然后每月返回一次，持续6个月。在每次回访时，受试者将完成呼出的一氧化碳测试，以及关于戒烟和溶液耐受性的问卷调查。主要结果是在戒烟日期后6个月继续戒烟。其他结果包括在1个月和3个月时继续戒烟、戒烟症状、治疗的副作用、治疗依从性和治疗溶液的感官效应。这项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，将对其安全性、有效性和机制进行进一步研究。

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.