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

项目总结 电子烟(EC)是一种有效的减少成年可燃香烟吸烟者的危害的策略 完全改用欧共体，但非洲裔美国人(AA)采用欧共体的速度较慢，代表性不足 在EC研究中，导致几乎完全缺乏关于EC作为一种减少危害策略的知识 对于与烟草相关的发病率和死亡率风险最高的群体。我们所知的相对较少 关于第四代尼古丁盐基POD系统(NSPS)，它是EC的主导类别。NSPS EC 尼古丁含量高，尼古丁输送速度快，便于独家切换。我们的飞行员 数据提供了强有力的初步证据，证明EC是AA吸烟者的一种减少伤害的策略，但有一个 迫切需要进行一项全能试验，并进行更长时间的随访。此外，加强EC的危害性 减少战略，迫切需要干预措施来支持双CIG-EC用户的独占切换 他们尝试过，但最初都失败了。不存在这样的干预。最近的一项开放标签研究发现，varenicline(VAR) 帮助双重吸烟者消除吸烟，但这一策略尚未在随机对照试验中进行测试。未能进行干预 拥有双重用户在EC用户中所占比例最大的群体中错失了机会(&>； 50%)，并且已经有动力减少吸烟对他们的危害。本申请的目标是1) 比较短期和长期减少伤害和滥用责任的潜力(即戒断、渴求、依赖) 在AA独占EC、双CIG-EC和独占CIG用户中的NSPS EC，2)描述预测对象的因素 开关完全、部分或完全不开关，以及3)检查是否可以通过治疗DUAL来进一步增强降低伤害 用户使用VAR来消除吸烟。目标将通过进行为期6周的开放- NSPS EC的标签试验和咨询，以促进AA吸烟者完全转向EC(n=500) 他们对戒除所有尼古丁产品不感兴趣，但有兴趣改用EC。我们加大了危害 通过为双用户提供额外支持来降低潜力并利用错失的机会 完全切换。在6周后，双重用户(n=~221)将额外获得12周的 NSPS EC，正在进行咨询，以进行完全转换，并随机接受12周的VAR或 支持戒除可燃香烟的安慰剂(PBO)。跟踪将持续一年，条件是， 知识，NSPC EC长期减少危害潜力的第一个证据。目前的研究是 第一个检查NSPS EC在优先人群中的短期和长期减少危害潜力，第一个 研究双重CIG-EC使用者完全改用EC的药理学支持。研究结果表明， 有可能支持EC作为一个完全不同的群体中的一项减少伤害战略，可以说这将使他们受益 最大限度地促进减少与烟草有关的发病率和死亡率的总体目标，并缩小 AA吸烟者的健康差距。

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.