Impact of exclusive use of low nicotine cigarettes on compensatory smoking

单独使用低尼古丁卷烟对补偿性吸烟的影响

• 批准号: 9440660
• 负责人: Tracy Taylor Smith
• 金额: $ 11.21万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-01 至 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9440660
• 关键词: Acetylcysteine; Biological Markers; Carbon Monoxide; Cessation of life; Cigarette; Clinical Data; Clinical Trials; Control Groups; Data; Environment; Environmental air flow; Expectancy; Exposure to; Family Smoking Prevention and Tobacco Control Act; Financial compensation; Goals; Health; Instruction; Intake; Investigation; Lead; Light; Masks; Measures; Nicotine; Nicotine Dependence; Participant; Patient Self-Report; Policies; Public Health; Publishing; Smoke; Smoker; Smoking; Smoking Behavior; Testing; Time; Tobacco; Toxicant exposure; United States; United States Food and Drug Administration; authority; behavior measurement; cigarette smoking; environmental tobacco smoke exposure; non-compliance; public health relevance; smoking prevalence; toxicant; urinary; volatile organic compound

ABSTRACT Smoking is the leading cause of preventable death in the United States. In 2009, the Food and Drug Administration was given the authority to regulate tobacco products, including the authority to reduce the nicotine content of cigarettes to any non-zero level. A drastic reduction in nicotine content could reduce the prevalence of smoking. However, one of the primary concerns regarding nicotine reduction is that smokers would increase their smoke intake—either through increasing the number of cigarettes smoked per day or changing the way they smoke—to obtain more nicotine. Nicotine reduction clinical trials have generally not found evidence of compensatory smoking. However, most participants in low nicotine groups use non-study cigarettes, despite explicit instructions to use only the study cigarettes provided to them. Thus, it is possible that an FDA-mandated reduction in the nicotine content of cigarettes could lead to compensatory smoking when normal nicotine content cigarettes are no longer available for purchase. The aim of the proposed study is to test the impact of nicotine reduction on smoking behavior and toxicant exposure when participants do not have access to normal nicotine content cigarettes. Twenty participants will be confined to a hotel setting for two four-night stays during which time they only have access to the investigational cigarettes provided to them. During one hotel stay they will have access to investigational normal nicotine content cigarettes, and during the other hotel stay they will only have access to investigational very low nicotine content cigarettes. To assess whether smokers engage in compensatory smoking as a result of nicotine reduction, biomarkers of smoke and toxicant exposure (urinary mercapturic acids, expired carbon monoxide) and behavioral measures of smoking (cigarettes smoked per day, puff topography) will be compared between the two conditions.

抽象的 吸烟是美国可预防死亡的主要原因。 2009年，食物和 药物管理局有权调节包括当局在内的烟草产品 将香烟的尼古丁含量降低到任何非零水平。尼古丁的急剧减少 内容可以减少吸烟的患病率。但是，主要问题之一 关心的尼古丁减少是吸烟者会增加烟雾的摄入量 增加每天抽烟的数量或改变吸烟的方式 - 获得 更多尼古丁。尼古丁还原临床试验通常找不到证据 补偿性吸烟。但是，低尼古丁群体中的大多数参与者都使用非研究 香烟，任务明确指示仅使用提供的研究香烟。那，它 可能会导致FDA降低香烟的尼古丁含量可能导致 当普通尼古丁含量香烟不再可用时，补偿性吸烟 购买。拟议的研究的目的是测试尼古丁减少对吸烟的影响 当参与者无法获得正常尼古丁时，行为和有毒物 满足香烟。二十名参与者将被限制在旅馆环境中，以进行两个四晚住宿 在此期间，他们只能使用提供给他们的调查卷烟。 在一次旅馆期间，他们将可以使用调查正常的尼古丁含量香烟， 在另一家酒店住宿期间，他们只能进入调查非常低的尼古丁 满足香烟。评估吸烟者是否由于 尼古丁还原，烟雾和有毒物质暴露的生物标志物（尿供胃酸， 过期的一氧化碳）和吸烟的行为度量（每天吸烟， 两种条件之间将比较粉扑地形）。