Low Nicotine Content Cigarettes in Vulnerable Populations: Affective Disorders

弱势群体中的低尼古丁含量香烟：情感障碍

• 批准号: 10247028
• 负责人: JENNIFER W. TIDEY
• 金额: $ 73.45万
• 依托单位: UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-30 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10247028
• 关键词: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol; Abstinence; Address; Anxiety Disorders; Behavior; Biological Markers; Brain; Carbon Monoxide; Cerebrovascular Circulation; Cessation of life; Cigarette; Dependence; Disease; Effectiveness; Electronic cigarette; Exhalation; Experimental Models; Funding; General Population; Goals; Health; Incentives; Interdisciplinary Study; Measures; Mental Health; Methods; Modeling; Mood Disorders; Nicotine; Nitric Oxide; Outcome Measure; Participant; Policies; Population; Randomized; Research; Sampling; Science; Smoke; Smoker; Source; Structure; Symptoms; Tobacco; Tobacco Dependence; Toxicant exposure; Universities; Vermont; Vulnerable Populations; Withdrawal; Work; addiction; adverse outcome; airway inflammation; base; behavioral economics; behavioral pharmacology; cigarette smoking; craving; design; experience; improved; innovation; low nicotine content cigarette; multi-site trial; programs; psychiatric symptom; recruit; reduce tobacco use; respiratory; response; smoking prevalence; tobacco flavor; tobacco toxicant; toxicant

Affective disorders (ADs; mood and anxiety disorders) are the most common mental health conditions in the US. Over 40% of people with ADs are current smokers, and they experience disproportionately high rates of tobacco-related disease and death. A national nicotine reduction policy for cigarettes has the potential to reduce tobacco dependence and improve health in these smokers. Controlled trials in general population samples have demonstrated that switching smokers to very low nicotine content cigarettes (VLNCCs) results in reductions in cigarettes per day (CPD), cigarette dependence, and tobacco toxicant exposure, with few adverse consequences. Furthermore, our work during the current funding period indicates that smokers with ADs respond to VLNCCs with reductions in cigarette demand and other measures of addiction. However, tobacco market conditions are likely to exert considerable influence over the effectiveness of a cigarette nicotine reduction policy. During the next funding period, we will utilize principles and methods of behavioral economics and behavioral pharmacology to examine the effects of VLNCCs in smokers with ADs, either alone or while providing a substitute non-combusted source of nicotine (e-cigarettes). In separate conditions, e-cigarettes will be provided in tobacco flavors only or in appealing personalized flavors. This multi-site trial uses a four parallel group, pragmatic design. Daily smokers with ADs will be randomized to 16 weeks of: (1) normal nicotine content cigarettes (NNCCs) alone, the control condition, (2) VLNCCs alone, (3) VLNCCs + nicotinized, tobacco-flavored (TF e-cigs), or (4) VLNCCs + nicotinized, preferred-flavored e-cigs (PF e-cigs). Outcome measures include CPD, product demand, craving, appeal, psychiatric symptoms, biomarkers of brain function, and biomarkers of tobacco toxicant exposure and airway inflammation. After 16 weeks of use, participants will undergo an abstinence assessment in which we examine the effects of the study conditions on participants’ ability to abstain from cigarettes and their responses to abstinence. The integrative theme of this TCORS is vulnerable populations. The proposed research is highly relevant to CTP’s scientific domains of Addiction and Behavior because it will examine whether reducing the nicotine content of cigarettes reduces cigarette use, dependence, and product appeal, and whether these effects are enhanced by the availability of e-cigarettes. It will address the Health Effects domain by assessing the effects of these conditions on biomarkers of brain function, tobacco toxicant exposure, and airway inflammation. The proposed study is significant and innovative because it will model how availability and appeal of e-cigs may moderate the effectiveness of a national reduced-nicotine policy for cigarettes in an understudied population. Finally, it is programmatic, as it will build upon the work that we accomplished during the current funding period. Overall, this proposal has the potential to continue a highly productive multidisciplinary research program and will provide FDA with critically important empirical evidence relevant to its regulatory responsibilities.

情感障碍（AD；情绪和焦虑症）是最常见的心理健康状况 我们。超过40％的广告患者是目前的吸烟者，他们经历的速度不成比例 与烟草有关的疾病和死亡。全国性的减少香烟政策有可能减少 烟草依赖并改善这些吸烟者的健康。一般人群样本中的对照试验具有 证明将吸烟者转换为非常低的尼古丁含量香烟（VLNCCS）导致减少 每天香烟（CPD），香烟依赖和烟草有毒物质暴露，几乎没有逆转 结果。此外，我们在当前资金期间的工作表明，有广告的吸烟者回应 对文明需求和其他成瘾措施减少的VLNCC。但是，烟草市场 条件可能会对尼古丁减少政策的有效性产生考虑影响。 在下一个资金期间，我们将利用行为经济学和行为的原则和方法 药理学以单独或提供替代品的同时检查VLNCC在吸烟者中的影响 尼古丁的非燃烧来源（电子烟）。在不同的条件下，将在烟草中提供电子烟 只有口味或出现个性化的口味。该多站点试验使用四个平行组的务实设计。 ADS的每日吸烟者将被随机分为16周：（1）单独的尼古丁含量香烟（NNCCS）， 控制条件，（2）单独使用vlnccs，（3）vlnccs +烟碱化，烟草味（tf e-cigs）或（4）vlnccs +烟碱化的，首选的味含电子烟（PF E-cigs）。结果指标包括CPD，产品需求，渴望， 吸引力，精神症状，脑功能的生物标志物以及烟草毒物的生物标志物和 气道炎症。使用16周后，参与者将接受节制评估 检查研究条件对参与者戒烟及其反应能力的影响 节制。该TCOR的综合主题是脆弱的人群。拟议的研究高度 与CTP成瘾和行为的科学领域有关，因为它将检查是否减少 香烟的尼古丁含量可减少香烟的使用，依赖性和产品外观，以及这些影响是否影响 电子烟的可用性增强了。它将通过评估健康影响领域来解决健康效应领域 这些条件对脑功能生物标志物，烟草毒性暴露和气道炎症的影响。 拟议的研究具有重大和创新性，因为它将模拟电子烟的可用性和外观 可能会减少国家减少烟碱政策对卷烟的有效性 人口。最后，它是程序化的，因为它将建立在我们当前完成的工作的基础上 资金期。总体而言，该提案有可能继续进行高生产力的多学科研究 计划，并将为FDA提供与其监管有关的至关重要的经验证据 职责。