Impact of exclusive use of low nicotine cigarettes on compensatory smoking

摘要 吸烟是美国可预防死亡的主要原因。2009年，食品和 美国药品管理局被授予管理烟草产品的权力， 将香烟中的尼古丁含量降至非零水平。尼古丁的急剧减少 内容可以减少吸烟的流行。然而，一个主要的问题是， 吸烟者会增加他们的吸烟量-无论是通过 增加每天吸烟的数量或改变他们吸烟的方式， 更多尼古丁减少尼古丁的临床试验通常没有发现证据 补偿性吸烟。然而，低尼古丁组的大多数参与者使用非研究 香烟，尽管明确指示仅使用提供给他们的研究香烟。因此 FDA强制要求降低香烟中尼古丁含量可能会导致 当正常尼古丁含量的香烟不再可用时， 购买.这项拟议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， 内容香烟20名参与者将被限制在酒店环境中进行两次四晚住宿 在此期间，他们只能接触提供给他们的研究用香烟。 在一次酒店住宿期间，他们将有机会获得研究正常尼古丁含量的香烟， 在其他酒店住宿期间，他们将只能获得研究用极低尼古丁 内容香烟评估吸烟者是否因吸烟而进行补偿性吸烟， 尼古丁减少，烟雾和毒物暴露的生物标志物（尿巯基尿酸， 呼出的一氧化碳）和吸烟的行为测量（每天吸的香烟， 抽吸形貌）将在两种条件之间进行比较。

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.