Evaluating the acute effects of caffeinated waterpipe tobacco

描述（由申请人提供）：本项目的具体目的是采用完整的、受试者内的2X2设计，比较吸烟含咖啡因水烟与吸烟含咖啡因不含尼古丁、尼古丁不含咖啡因、或既不含咖啡因也不含尼古丁的水烟制品的主观和心血管影响。同时使用咖啡因的水烟吸烟志愿者将完成所有四个条件，结果测量包括血浆尼古丁和咖啡因水平、心血管反应、主观影响和吸烟行为。主要的假设是，含咖啡因的水烟会增加血浆中尼古丁和咖啡因的水平，并产生比不含咖啡因的水烟更大的心血管和主观影响。更广泛地说，这项研究将评估一种新的咖啡因/尼古丁传递系统（通过挥发），也将有助于告知这些产品的用户。相关性：尽管吸烟水平处于过去20年来的最低水平，但与烟草使用有关的发病率和死亡率仍然高得惊人。水烟管吸烟是一种替代形式的烟草使用，在美国变得越来越普遍，它提供的生理活性尼古丁剂量可能会增加随后吸烟的可能性。大多数烟草使用者自己服用另一种温和的兴奋剂——咖啡因，研究表明，咖啡因与尼古丁混合摄入会增强尼古丁的效果。水烟吸烟者有一种独特的方法来共同服用这两种药物：含咖啡因的水烟。然而，目前还没有关于尼古丁和咖啡因的综合影响的数据。因此，该项目解决了一个日益严重的公共卫生问题（水烟吸烟），同时提供了有关尼古丁和咖啡因混合吸烟影响的新信息。

DESCRIPTION (provided by applicant): This project's specific aims are to compare, using a complete, within-subjects, 2X2 design, the subjective and cardiovascular effects of smoking caffeinated waterpipe tobacco with the effects of smoking waterpipe preparations containing caffeine and no nicotine, nicotine and no caffeine, or neither caffeine nor nicotine. Waterpipe tobacco smoking volunteers who also use caffeine will complete all four conditions, and outcome measures include plasma nicotine and caffeine levels, cardiovascular response, subjective effects, and smoking behavior. The primary hypothesis is that caffeinated waterpipe tobacco increases plasma nicotine and caffeine levels and produces cardiovascular and subjective effects that are greater than non-caffeinated waterpipe tobacco. More generally, this study will evaluate a novel delivery system of caffeine/nicotine (via volatilization) and will also help inform users of these products. Relevance: Despite the fact that smoking levels are their lowest over the past 20 years, morbidity and mortality associated with tobacco use are still alarmingly high. Waterpipe tobacco smoking is an alternative form of tobacco use that is becoming increasingly common in the U.S. and delivers physiologically active nicotine doses that may increase the probability of subsequent tobacco use. A majority of tobacco users self-administer another mild stimulant, caffeine, which has been shown to enhance the effects of nicotine when ingested in combination. Waterpipe tobacco smokers have a unique method to co-administer these two drugs: caffeinated waterpipe tobacco. However, there are no data regarding the combined effects of smoked nicotine and caffeine. Thus, this project addresses a growing public health issue (waterpipe tobacco smoking) while providing novel information regarding the effects of nicotine and caffeine when smoked in combination.