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申请解决了美国过早死亡的主要可预防原因，即吸烟。最广泛使用的帮助吸烟者戒烟的治疗方法是尼古丁替代疗法，但其成功率在六个月内只有20%左右。基于涉及尼古丁、感觉和习惯效应的吸烟行为模型，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增加安慰剂对照组来进一步开发口服尼古丁。 本研究是一项两组、平行设计、安慰剂对照、随机临床试验。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（活性条件）或碘茶碱溶液（对照条件）。将指导受试者根据需要每小时将溶液添加到他们选择的饮料中，持续6周。所有受试者将接受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大都市地区招募。入选标准为：1）年龄18-65岁2）每天至少吸烟10支3）戒烟愿望4）愿意在入组后14天内设定“戒烟日期”。主要排除标准为：1）任何需要监测的持续性医学问题2）处方药3）妊娠或哺乳。 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。受试者将在退出日期返回，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，受试者将完成呼出一氧化碳试验，以及关于戒烟和溶液耐受性的问卷调查。主要结局是戒烟日期后6个月的持续戒烟。其他结局包括1个月和3个月时的持续戒烟、戒烟症状、治疗副作用、治疗依从性和治疗溶液的感觉效应。 这项研究测试了一种有前途的新型尼古丁替代疗法与安慰剂相比的初步疗效。如果有效，将对其安全性，有效性和机制进行进一步研究。