Nicotine delivery from novel non tobacco electronic systems

新型非烟草电子系统的尼古丁输送

• 批准号: 8685592
• 负责人: Maciej Lukasz Goniewicz
• 金额: $ 44.87万
• 依托单位: ROSWELL PARK CANCER INSTITUTE CORP
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-01 至 2017-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8685592
• 关键词: Address; Affect; Appearance; Behavior; Biological; Blood Circulation; Breathing; Characteristics; Cigarette; Clinical; Clinical Research; Devices; Dose; Drug Kinetics; Electronics; Elements; Engineering; Flavoring; Goals; Heating; Human body; Label; Laboratories; Liquid substance; Marketing; Measures; Methods; Modeling; Nature; Nicotine; Nicotine Inhaler; Procedures; Process; Protocols documentation; Research Project Grants; Smoking; Solutions; Solvents; System; Testing; Tobacco; Withdrawal Symptom; analytical method; cigarette smoking; craving; evidence base; novel; public health relevance; vapor; vaporization

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.

描述(由申请人提供)：电子尼古丁输送装置(END)是一种新型产品，它以电子方式产生一种含有尼古丁的蒸气，然后由使用者吸入。市场上最受欢迎的烟头是电子烟，但不同的烟头类型和品牌设计不同。这些差异包括溶液的物理外观、尼古丁溶剂、尼古丁浓度和风味添加剂、包含溶液的墨盒的容量、加热元件的性质以及电池的大小和类型。 由于大多数烟头含有尼古丁，并以类似于吸烟的方式产生可吸入的蒸汽，我们的总体假设是，烟头可能是一种有效的尼古丁输送装置。本研究项目的主要目标是评估各种电子尼古丁递送系统(END)的质量和效果。其次，我们的目标是建立一个证据基础，以评估它们向使用者输送尼古丁的潜力。这项研究将调查不同品牌和型号的烟头，以测量重新灌装的液体、药筒和蒸气中的尼古丁水平。我们还将完成实验室测试，以调查各种工程特性如何影响产品使用者吸入的尼古丁产量。我们将进行短期临床研究，评估尼古丁从不同类型的末端进入人体的情况，包括与传统香烟的比较。然后，这些发现可以向FDA提供有关制定和实施标准质量程序和END测试方法的信息。我们的具体目标如下：具体目标1-产品特性(实验室)：我们的第一个目标是确定各种品牌和类型的终端中存在的尼古丁数量，以及设备产生的蒸气中的尼古丁产量。特定目的尼古丁释放水平(临床)：我们将进行药代动力学(PK)研究，以确定各种类型的末端有效地传递到血液中的尼古丁水平，并将其与传统香烟传递的水平进行比较。我们将探索在尼古丁溶液中添加调味品对烟尘地形和尼古丁从末端输送的影响。具体目标3-制定将反映用户吹气行为和产品特征的标准化终端测试协议(翻译)：我们将为各种类型的终端制定标准化测试协议。