Nicotine delivery from novel non tobacco electronic systems

描述（由申请人提供）：电子尼古丁输送装置（ENDS）是一种新型产品，可通过电子方式产生含尼古丁的蒸汽，然后由用户吸入。市场上最受欢迎的ENDS是电子烟，但不同的ENDS类型和品牌设计不同。这些差异包括物理外观、尼古丁溶剂、尼古丁浓度和溶液中的风味添加剂、含有溶液的药筒的容量、加热元件的性质以及电池的尺寸和类型。 由于大多数ENDS含有尼古丁，并以类似于吸烟的方式产生可吸入蒸汽，因此我们的总体假设是ENDS可能是一种有效的尼古丁输送装置。该研究项目的主要目标是评估各种电子尼古丁输送系统（ENDS）的质量和功效。其次，我们的目标是建立一个证据基础，以评估其向用户提供尼古丁的潜力。本研究将调查各种品牌和型号的ENDS，以测量再填充液体，墨盒和蒸汽中的尼古丁水平。我们亦会完成实验室测试，研究不同的工程特性如何影响产品使用者吸入的尼古丁量。我们将进行短期临床研究，评估不同类型的ENDS向人体输送尼古丁的情况，包括与传统香烟进行比较。然后，这些发现可以为FDA制定和实施ENDS的标准质量程序和测试方法提供信息。我们的具体目标如下：具体目标1 -产品表征（实验室）：我们的第一个目标是确定各种品牌和类型的末端中存在的尼古丁含量，以及器械产生的蒸汽中的尼古丁含量。具体目标2 -尼古丁递送水平（临床）：我们将进行药代动力学（PK）研究，以确定各种类型的ENDS有效递送到血流中的尼古丁水平，并将其与传统香烟递送的水平进行比较。我们将探讨添加到尼古丁溶液中的调味剂对ENDS的膨化地形和尼古丁释放的影响。具体目标3 -

DESCRIPTION (provided by applicant): Electronic nicotine delivery devices (ENDS) are novel products that electronically generate a nicotine- containing vapor that is then inhaled by the user. The most popular ENDS on the market are electronic cigarettes, but different ENDS types and brands are engineered differently. The differences include the physical appearance, the nicotine solvent, nicotine concentration and flavor additives to the solution, the capacity of the cartridge containing the solution, the nature of the heating element, and size and type of battery. Since the majority of ENDS contain nicotine and generate inhalable vapor in a manner similar to cigarette smoking, our overall hypothesis is that ENDS might be an effective nicotine delivery device. The primary goal of this research project is to evaluate the quality and efficacy of various electronic nicotine delivery systems (ENDS). Secondarily, we aim to establish an evidence base for evaluating their potential for nicotine delivery to users. This study will investigate various brands and models of ENDS to measure nicotine levels in refill liquids, cartridges, and vapor. We will also complete laboratory testing to investigate how various engineering characteristics influence nicotine yields inhaled by users of the products. We will conduct short- term clinical studies to assess nicotine delivery to the human body from various types of ENDS, including comparisons with conventional cigarettes. The findings can then inform FDA on developing and implementing standard quality procedures and testing methods for ENDS. Our specific aims are as follows: SPECIFIC AIM 1 - PRODUCT CHARACTERIZATION (LABORATORY): Our first aim is to determine the amounts of nicotine present in various brands and types of ENDS, and nicotine yields in vapors generated from the devices. SPECIFIC AIM 2 - DELIVERED LEVELS OF NICOTINE (CLINICAL): We will conduct pharmacokinetic (PK) studies to determine the levels of nicotine effectively delivered by various types of ENDS into the bloodstream and compare them to levels delivered by conventional cigarettes. We will explore the effects of flavorings added to a nicotine solution on puffing topography and nicotine delivery from ENDS. SPECIFIC AIM 3 - DEVELOP A STANDARDIZED TESTING PROTOCOL FOR ENDS THAT WILL REFLECT USERS' PUFFING BEHAVIOR AND PRODUCT CHARACTERISTICS (TRANSLATIONAL): We will develop a standardized testing protocol for various types of ENDS.