Innovative Interventions for Smoking Cessation

创新的戒烟干预措施

• 批准号: 7564275
• 负责人: DOROTHY K HATSUKAMI
• 金额: $ 45.79万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-08-01 至 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7564275
• 关键词: Abstinence; Achievement; Advocate; Affect; African American; Aftercare; Attention; Behavior Therapy; Behavioral; Biological Markers; Burn injury; Cause of Death; Cigarette; Cigarette Smoker; Clinical Trials; Complement; Controlled Clinical Trials; Dependence; Devices; Disease; Dose; Drug Formulations; Exposure to; Future; Goals; Grant; Harm Reduction; Health; Heating; Individual; Intervention; Marketing; Metabolism; Methods; Morbidity - disease rate; Motivation; Nicotine; Nitrosamines; Oral; Oral Tobacco; Outcome Measure; Pharmacologic Substance; Pharmacotherapy; Policies; Publications; Randomized; Research; Research Personnel; Research Project Grants; Risk; Sensory; Smoke; Smoker; Smoking; Smoking Cessation Intervention; Speed; Surface; System; Testing; Time; Tobacco; Tobacco Use Cessation; Tobacco use; Toxic effect; Toxicant exposure; United States Dept. of Health and Human Services; Withdrawal Symptom; Woman; addiction; base; cigarette smoking; craving; depressive symptoms; disorder risk; experience; improved; innovation; men; mortality; nicotine gum; nicotine patch; novel; potential reduced exposure products; public health relevance; smoking cessation; success; tobacco abstinence; tobacco control; toxicant; treatment response; trend

DESCRIPTION (provided by applicant): Innovative strategies for tobacco cessation must be considered. Currently, there are 44 million smokers in the US and 1.2 billion smokers world-wide. Although 22 million smokers try to quit smoking each year, only 3-5% are successful in becoming sustained abstainers. Even with the best treatments which combine pharmacotherapy and behavioral treatment, on average long-term abstinence rates are around 25%. Furthermore, at any one time, only 4-20% of smokers are ready to quit smoking. Unless there is a dramatic change in the trends, by year 2025, it is anticipated that 10 million smokers will die per year world-wide from tobacco-caused diseases. Recent publications and discussions have focused on the tobacco product as target for reducing tobacco-related morbidity and mortality by either reducing toxicants and/or nicotine in the product or by altering the delivery system. These types of potential reduced exposure products (PREPs) have been increasingly surfacing in the U.S. market. A strategy to utilize these products in conjunction with existing pharmaceutical products may provide a novel method to help people who are unable to quit through traditional cessation methods or may improve on existing pharmacotherapies. Examining PREPs that primarily manipulate nicotine dose and speed of nicotine delivery would be particularly instructive in understanding potential treatment targets and methods that will enhance cessation success. To this end, this propose study will randomize cigarette smokers to: 1) Lower nitrosamines, high and rapid nicotine delivery oral tobacco products for 4 weeks and then nicotine patch alone for an additional 4 weeks; 2) denicotinized cigarettes (which provides sensory behavioral aspects of smoking) plus nicotine patch for 4 weeks and nicotine patch alone for an additional 4 weeks; or 3) nicotine gum or lozenge plus nicotine patch for 4 weeks and then nicotine patch alone for 4 weeks, with the goal of abstinence. Outcome measures will include withdrawal symptoms and craving, time to lapse to usual brand of cigarettes, cessation assessed at the end of treatment and at 12 and 24 weeks post-treatment, and biomarkers of exposure and toxicity. Predictors of treatment response for each of the treatment conditions will also be explored. The results of this project should provide valuable information on innovative methods for reducing tobacco toxicant exposure and promoting cessation and a better understanding of the underlying mechanisms of and contributors to treatment response. Furthermore, the results from this study will provide guidance for future large, longer-term clinical trials to test promising interventions and will also provide guidance for policy directions. PUBLIC HEALTH RELEVANCE: This project will examine innovative strategies for cigarette smoking cessation. Currently marketed tobacco products that result in reduced tobacco toxicant exposure will be used in conjunction with medicinal nicotine to provide a novel method to help smokers quit smoking. These tobacco products will vary in level of nicotine dose and speed of nicotine delivery and smokers will graduate from these products to using solely medicinal nicotine products prior to complete cessation. The results of this study will provide useful information on directions to pursue to improve our pharmacotherapies and behavioral treatments and to better understand the various aspects of addiction.

描述（由申请人提供）：必须考虑烟草戒烟的创新策略。目前，美国有4400万吸烟者和全球12亿吸烟者。尽管每年有2200万吸烟者试图戒烟，但只有3-5％的吸烟者成功地弃权。即使结合了药物治疗和行为治疗的最佳治疗方法，平均长期禁欲率也约为25％。此外，任何一次，只有4-20％的吸烟者准备戒烟。除非趋势发生巨大变化，否则到2025年，预计1000万吸烟者每年将因烟草引起的疾病而死亡。最近的出版物和讨论集中在烟草产品上，是通过减少产品中的毒物和/或尼古丁的降低烟草相关发病率和死亡率的目标，或者通过改变递送系统。这些潜在的减少暴露产品（PREP）在美国市场越来越多地浮出水面。与现有药品结合使用这些产品的策略可能会提供一种新颖的方法来帮助无法通过传统戒烟方法戒烟或可能改善现有药物治疗的人们。检查主要操纵尼古丁剂量和尼古丁递送速度的预备在理解潜在的治疗靶标和方法方面特别有才能，从而增强了停止成功。为此，这项提出的研究将将吸烟者随机化为：1）降低亚硝胺，高和快速的尼古丁递送口服烟草产品4周，然后单独使用尼古丁贴剂，持续4周； 2）否认香烟（提供吸烟的感觉行为方面）加上尼古丁斑块4周，仅尼古丁斑块又有4周；或3）尼古丁口香糖或润zenge和尼古丁贴剂4周，然后仅尼古丁贴剂4周，其目标是禁欲。结局指标将包括戒断症状和渴望，时间到通常的品牌，在治疗结束时和治疗后12和24周评估的戒烟以及暴露和毒性的生物标志物。还将探讨每种治疗条件的治疗反应的预测因子。该项目的结果应提供有关减少烟草有毒物质暴露和停止的创新方法的宝贵信息，并更好地理解治疗反应的基本机制和贡献者。此外，这项研究的结果将为未来的大型长期临床试验提供指导，以测试有前途的干预措施，还将为政策方向提供指导。 公共卫生相关性：该项目将研究戒烟的创新策略。目前，将与药用尼古丁一起使用销售的烟草产品，从而减少烟草毒物的毒性暴露，以提供一种新的方法来帮助吸烟者戒烟。这些烟草产品的尼古丁剂量和尼古丁递送速度的水平会有所不同，吸烟者将从这些产品毕业，直到完全停止之前使用纯药用尼古丁产品。这项研究的结果将提供有关追求方向的有用信息，以改善我们的药物治疗和行为治疗，并更好地了解成瘾的各个方面。