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: 9118948
• 负责人: Maciej Lukasz Goniewicz
• 金额: $ 51.14万
• 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 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9118948
• 关键词: Address; Affect; Appearance; Behavior; Biological; Blood Circulation; Breathing; Characteristics; Cigarette; Clinical; Clinical Research; Devices; Dose; Drug Kinetics; Electronic cigarette; 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; 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）：电子尼古丁递送设备（末端）是电子产生含有尼古丁的蒸气的新型产品，然后由用户吸入。市场上最受欢迎的目的是电子烟，但是不同的末端类型和品牌的设计方式不同。差异包括物理外观，尼古丁溶剂，尼古丁浓度和溶液的味道添加剂，包含溶液的墨盒的容量，加热元件的性质以及电池的尺寸和类型。 由于大多数末端含有尼古丁，并以类似于吸烟的方式产生可吸入的蒸气，因此我们的总体假设是末端可能是有效的尼古丁递送装置。该研究项目的主要目标是评估各种电子尼古丁传递系统（末端）的质量和功效。其次，我们旨在建立一个证据基础，以评估其向用户传递尼古丁的潜力。这项研究将研究各种品牌和末端模型，以测量含液体，墨盒和蒸气中的尼古丁水平。我们还将完成实验室测试，以研究各种工程特征如何影响产品用户吸入的尼古丁产量。我们将进行短期的临床研究，以评估各种类型的尼古丁传递到人体，包括与常规香烟的比较。然后，这些发现可以告知FDA，以开发和实施标准质量程序和目的测试方法。我们的具体目的如下：特定目标1-产品特征（实验室）：我们的第一个目的是确定各种品牌和目的类型中存在的尼古丁的量，以及设备产生的蒸气中的尼古丁产量。具体目标2-递送的尼古丁水平（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，并将其与传统香烟交付的水平进行比较。我们将探索添加到尼古丁溶液中的调味剂对膨化地形和尼古丁从末端递送的影响。特定目标3-为目的制定标准化的测试协议，该协议将反映用户的浮肿行为和产品特征（翻译）：我们将为各种类型的目的开发标准化的测试协议。

项目成果

Nicotine levels in electronic cigarette refill solutions: A comparative analysis of products from the U.S., Korea, and Poland.

• DOI: 10.1016/j.drugpo.2015.01.020
• 发表时间: 2015-06
• 期刊: INTERNATIONAL JOURNAL OF DRUG POLICY
• 影响因子: 4.4
• 作者: Goniewicz, Maciej L.;Gupta, Ribhav;Lee, Yong Hee;Reinhardt, Skyler;Kim, Sungroul;Kim, Bokyeong;Kosmider, Leon;Sobczak, Andrzej
• 通讯作者: Sobczak, Andrzej

E-Cigarettes and Toxin Exposure.

电子烟和毒素暴露。

• DOI: 10.7326/l17-0315
• 发表时间: 2017
• 期刊: Annals of internal medicine
• 影响因子: 39.2
• 作者: Shahab,Lion;Goniewicz,MaciejL;Blount,BenjaminC;Brown,Jamie;West,Robert
• 通讯作者: West,Robert

Cherry-flavoured electronic cigarettes expose users to the inhalation irritant, benzaldehyde.

• DOI: 10.1136/thoraxjnl-2015-207895
• 发表时间: 2016-04
• 期刊: Thorax
• 影响因子: 10
• 作者: Kosmider L;Sobczak A;Prokopowicz A;Kurek J;Zaciera M;Knysak J;Smith D;Goniewicz ML
• 通讯作者: Goniewicz ML