4th Generation e-cigarettes in African American Smokers: Reducing Harm and Quitting Combustible Cigarettes in Dual Users

第四代电子烟对非裔美国吸烟者的影响：减少双重使用者的危害并戒掉可燃香烟

• 批准号: 10622313
• 负责人: NICOLE L NOLLEN
• 金额: $ 64.3万
• 依托单位: UNIVERSITY OF KANSAS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-14 至 2027-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10622313
• 关键词: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol; Adopted; Adult; Adverse event; African American; Biological Markers; Characteristics; Cigarette; Cigarette Smoker; Clinical Trials; Counseling; Data; Dependence; Disparity population; Electronic cigarette; Failure; Generations; Goals; Harm Reduction; Health; Human; Interleukin-9; Intervention; Knowledge; MMP8 gene; Morbidity - disease rate; Motivation; Nicotine; Participant; Pattern; Perception; Placebos; Population; Predictive Factor; Randomized; Randomized, Controlled Trials; Research; Respiratory Signs and Symptoms; Smoker; Smoking; Smoking History; Sodium Chloride; System; Testing; Tobacco; Toxicant exposure; Withdrawal; abuse liability; cigarette smoking; cigarette user; combustible cigarette; craving; disparity gap; electronic cigarette use; electronic cigarette user; experience; follow-up; health disparity; high risk; interest; mortality; nicotine exposure; nicotine use; open label; pharmacologic; primary endpoint; primary outcome; public health relevance; respiratory; side effect; social norm; varenicline; week trial

PROJECT SUMMARY E-cigarettes (EC) are an effective harm reduction strategy in adult combustible cigarette smokers who exclusively switch to EC, yet African American (AA) have been slower to adopt EC and are underrepresented in EC research, contributing to an almost complete lack of knowledge about EC as a harm reduction strategy for a group experiencing the highest risk of tobacco-related morbidity and mortality. Relatively little is known about 4th generation nicotine salt-based pod systems (NSPS), which are the leading class of EC. NSPS EC contain high nicotine concentrations with rapid nicotine delivery that facilitates exclusive switching. Our pilot data provide strong preliminary evidence of EC as a harm reduction strategy for AA smokers but there is an urgent need to conduct a fully powered trial with longer follow-up. Moreover, to enhance EC as a harm reduction strategy, there is a critical need for interventions to support exclusive switching in dual cig-EC users who try but initially fail. No such interventions exist. A recent open label study found that varenicline (VAR) helped dual users eliminate cigarette use but this has strategy not been tested in an RCT. Failure to intervene with dual users is a missed opportunity among a group who comprises the largest proportion of EC users (> 50%) and is already motivated to reduce their harm from smoking. The objectives of this application are to 1) compare short- and long-term harm reduction and abuse liability potential (i.e., withdrawal, craving, dependence) of a NSPS EC in AA exclusive EC, dual cig-EC, and exclusive cig users, 2) characterize factors that predict who switches fully, partially, or not at all, and 3) examine if harm reduction can be further enhanced by treating dual users with VAR to eliminate cigarette smoking. Objectives will be accomplished by conducting a 6-week open- label trial of a NSPS EC and counseling to facilitate a complete switch to EC in AA cigarette smokers (n=500) who are not interested in quitting all nicotine products but are interested in switching to EC. We enhance harm reduction potential and capitalize on a missed opportunity by offering dual users additional support to make a complete switch. At six weeks, those who are dual users (n= ~221) will receive an additional 12 weeks of the NSPS EC, ongoing counseling to make a complete switch, and be randomized to receive 12 weeks of VAR or placebo (PBO) to support quitting combustible cigarettes. Follow-up will continue for one-year, providing, to our knowledge, the first evidence on the long-term harm reduction potential of NSPC EC. The current study is the first to examine the short- and long-term harm reduction potential of NSPS EC in a priority population and the first to examine pharmacological support for dual cig-EC users in making a complete switch to EC. Findings have the potential to support EC as a harm reduction strategy among a disparate group that arguably stands to benefit from it the most, contribute to the overall goal of reducing tobacco-related morbidity and mortality, and narrow the health disparity gap for AA smokers.

项目摘要 电子烟（EC）是一种有效的减少成年可燃香烟吸烟者危害的策略， 完全转向欧共体，但非裔美国人（AA）采用欧共体较慢，而且代表性不足 在欧共体研究中，导致几乎完全缺乏关于欧共体作为减少危害战略的知识， 烟草相关疾病和死亡风险最高的群体。知之甚少 第四代尼古丁盐基豆荚系统（NSPS）是目前领先的EC类。NSPS EC 含有高尼古丁浓度，尼古丁输送迅速，便于排他性转换。我们的飞行员 数据提供了强有力的初步证据，表明EC是AA吸烟者的一种减少危害的策略， 迫切需要进行一项具有更长随访期的充分把握度试验。此外，为了增强EC作为一种危害， 减少战略，迫切需要干预措施，以支持双重cig-EC用户的独家转换 他们尝试过但一开始失败了不存在这种干预。最近的一项开放标签研究发现，伐尼克兰（VAR） 帮助双重使用者消除吸烟，但这一策略尚未在RCT中进行过测试。未能干预 对于占电子商务用户比例最大的群体来说， 50%），并且已经有动机减少吸烟的危害。本申请的目的是1） 比较短期和长期减少危害和滥用责任的潜力（即，戒断、渴望、依赖） 的NSPS EC在AA独家EC，双cig-EC，和独家cig用户，2）表征因素，预测谁 完全、部分或根本不切换，以及3）检查是否可以通过治疗双重 使用VAR来消除吸烟。目标将通过开展为期6周的开放式- NSPS EC标签试验和咨询，以促进AA卷烟吸烟者完全转换为EC（n=500） 没有兴趣戒掉所有尼古丁产品，但有兴趣改用EC。我们增加伤害 通过为双用户提供额外支持， 完全的转变在第6周，双重使用者（n= ~221）将额外接受12周的 NSPS EC，持续咨询以进行完全转换，并随机接受12周VAR或 安慰剂（PBO），以支持戒烟可燃香烟。随访将持续一年，如果我们的 知识，这是NSPC EC长期减少危害潜力的第一个证据。目前的研究是 第一次检查NSPS EC在优先人群中的短期和长期危害减少潜力， 研究药物支援，以协助使用两种香烟及氨基甲酸乙酯的人士完全转用氨基甲酸乙酯。调查结果显示， 有可能支持EC作为一个不同群体的减少危害战略， 其中最重要的是，有助于实现减少与烟草有关的发病率和死亡率的总体目标， AA吸烟者的健康差距。