Cigarette Harm Reduction with Scheduled Electronic Cigarette Use

通过定期使用电子烟减少香烟危害

基本信息

批准号：
9752505
负责人：
NEAL L BENOWITZ
金额：
$ 79.05万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-08-15 至 2024-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9752505
关键词：
Address Anabasine Aromatic Polycyclic Hydrocarbons Behavior Biological Biological Markers Blood Pressure Cardiovascular system Catecholamines Chemical Exposure Cigarette Cigarette Smoker Clinical Pharmacology Clinical Research Collection Cotinine Data Devices Drug Kinetics Electronic cigarette Ensure Excretory function Exposure to Goals Harm Reduction Health Heart Rate Hormonal Inflammation Intake Investigation Laboratories Modeling National Institute of Drug Abuse Nicotine Pattern Pharmacology Pharmacology and Toxicology Platelet Activation Recording of previous events Research Rewards Safety Schedule Sensitivity and Specificity Smoker Smoking Standardization Thrombosis Time Titrations Tobacco Tobacco smoke Toxicant exposure Urine Withdrawal Withdrawal Symptom cardiovascular effects cardiovascular health cigarette smoking circadian craving design electronic cigarette use electronic liquid individual variation nicotine exposure nicotine use oxidant stress risk perception satisfaction tobacco exposure tobacco smoke exposure toxicant urinary volatile organic compound ward

项目摘要

PROJECT SUMMARY/ABSTRACT One of the major reasons cited for the use of electronic cigarettes (EC) is to reduce harm from smoking. Harm reduction using EC might be accomplished by smoking fewer conventional tobacco cigarettes (TC) per day, or switching completely form TC to EC. To date there are relatively few data on health consequences of EC use for harm reduction. Our laboratory has been conducting research on the clinical pharmacology and toxicology of ECs for several years. Our approach has been intensive investigation of use behaviors, chemical exposures and biological effects of EC compared to TC use in subjects confined to a research ward setting. We propose to use a similar research approach to study harm reduction questions with the use of the newly-developed NIDA Standardized Research E-cigarette (SREC). Our overall goals are two-fold: (1) to compare nicotine and toxicant exposure and pharmacological effects of SREC used alone vs TC; and (2) using scheduled SREC use combined with ad libitum TC use as a model for dual use, to examine the extent to which nicotine and toxicant exposure and biomarkers of potential harm compare with dual use vs TC alone use. The former would inform the effects of total switching, the latter would inform the potential harm reducing effects of smoking fewer TC while using EC. Daily cigarette smokers who are familiar with EC use will be instructed to use only SREC and TC, each for one week at time. On a third week they will be instructed to use SREC on a schedule 8 times per day, and be free otherwise to use either SREC or TC as desired. For the last three days of each week, subjects will be confined to a clinical research unit to ensure strict compliance with product use and for intensive data and biospecimen collection. We will: (1) examine SREC as a nicotine delivery device, including individual variability in nicotine intake and pharmacokinetics, temporal patterns of use and titration of nicotine, compared to TC use; (2) examine subjective effects of SREC use, including relationship of pattern and extent of use and nicotine levels to reward, withdrawal and craving, with comparison to TC use; (3) examine aspects of safety of SREC use (by assessment of cardiovascular and hormonal effects of use and of biomarkers of exposure to potentially toxic constituents); (4) compare nicotine and toxicant exposure, subjective effects and cardiovascular and hormonal effects of TC alone vs dual SREC/TC use (harm reduction assessment) and (5) validate biomarkers that may be useful in distinguishing EC from TC use. The proposed research will provide essential information on the clinical pharmacology and toxicology of SREC, and on the potential for smoking fewer TC per day supported by dual use of SREC to reduce adverse cardiovascular health effects of TC use alone.

项目概要/摘要使用电子烟（EC）的主要原因之一是减少吸烟的危害。伤害使用 EC 的减少可以通过每天减少吸传统烟草卷烟 (TC) 的数量来实现，或者完全从 TC 切换到 EC。迄今为止，关于使用 EC 对健康造成的影响的数据相对较少以减少伤害。我们实验室多年来一直致力于ECs的临床药理毒理学研究年。我们的方法是对使用行为、化学暴露和生物接触进行深入调查 EC 与 TC 在研究病房环境中使用的效果相比。我们建议使用类似的使用新开发的 NIDA 标准化研究方法来研究减少危害问题研究电子烟（SREC）。我们的总体目标有两个：（1）比较尼古丁和毒物的暴露以及药理作用单独使用SREC vs TC； (2) 使用预定的 SREC 结合随意使用 TC 作为模型双重用途，检查尼古丁和有毒物质暴露的程度以及潜在危害的生物标志物与双重使用与 TC 单独使用进行比较。前者将告知总切换的效果，后者将告知使用 EC 时减少吸食 TC 的潜在危害。熟悉 EC 使用的每日吸烟者将被指示仅使用 SREC 和 TC，各一支一周一次。在第三周，他们将被指示每天按计划使用 SREC 8 次，并且免费否则根据需要使用 SREC 或 TC。每周的最后三天，科目将被限制到临床研究单位，以确保严格遵守产品使用以及密集数据和生物样本收藏。我们将：(1) 检查 SREC 作为尼古丁输送装置，包括尼古丁的个体差异与 TC 使用相比，尼古丁的摄入量和药代动力学、使用时间模式和滴定； (2) 检查 SREC 使用的主观影响，包括使用模式和程度与尼古丁水平的关系与 TC 的使用相比，奖励、戒断和渴望； (3) 检查 SREC 使用的安全性方面（通过评估使用的心血管和激素影响以及接触潜在有毒物质的生物标志物成分）； (4) 比较尼古丁和毒物暴露、主观影响以及心血管和激素单独使用 TC 与同时使用 SREC/TC 的效果（危害减少评估）以及 (5) 验证可能的生物标志物可用于区分 EC 和 TC 的使用。拟议的研究将提供有关 SREC 临床药理学和毒理学的重要信息，以及双重使用 SREC 的支持下每天吸食更少 TC 的潜力，以减少不良反应单独使用 TC 对心血管健康的影响。