Cigarette Harm Reduction with Scheduled Electronic Cigarette Use

通过定期使用电子烟减少香烟危害

• 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
• 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

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.

项目总结/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 减少使用EC可以通过每天少吸传统烟草香烟（TC）来实现，或者 完全从TC转换到EC。迄今为止，关于使用氨基甲酸乙酯对健康造成的后果的数据相对较少 减少伤害。 我们的实验室已经进行了几年的临床药理学和毒理学研究。 年我们的方法一直是深入调查使用行为，化学品暴露和生物 EC的影响相比，TC使用的受试者局限于研究病房设置。我们建议使用类似的 使用新开发的NIDA标准化研究减少危害问题的研究方法 电子烟（SREC） 我们的总体目标有两个方面：（1）比较尼古丁和有毒物质的暴露以及 SREC单独使用vs TC;和（2）使用计划的SREC使用与随意TC使用相结合作为模型， 双重用途，以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 与单独使用TC相比，前者将告知总转换的影响，后者将 告知使用EC时吸烟较少TC的潜在危害减少效果。 熟悉EC使用的日常吸烟者将被指示仅使用SREC和TC，每种一种 一周的时间。在第三周，他们将被指示每天使用SREC 8次，并且是免费的 否则根据需要使用SREC或TC。每周的最后三天，受试者将被限制在 临床研究单位，以确保严格遵守产品使用和密集的数据和生物标本 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 奖励，戒断和渴望，与TC使用相比;（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效应以及暴露于潜在毒性物质的生物标志物 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 TC单独使用与SREC/TC双重使用的影响（危害降低评估）和（5）验证可能 有助于区分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基本信息， 以及在双重使用SREC的支持下每天吸烟更少TC的可能性，以减少不良反应 单独使用TC对心血管健康的影响。