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: 10477408
• 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 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10477408
• 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; Persons; 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；情绪和焦虑障碍）是当今世界最常见的心理健康状况 我们。超过 40% 的 AD 患者目前吸烟，而且他们的吸烟率异常高。 与烟草有关的疾病和死亡。国家香烟尼古丁减少政策有可能减少 烟草依赖并改善这些吸烟者的健康。在一般人群样本中进行的对照试验 证明吸烟者改吸尼古丁含量极低的香烟（VLNCC）可以减少尼古丁含量 每天吸烟量（CPD）、香烟依赖和烟草毒物暴露，几乎没有不良影响 结果。此外，我们在当前资助期间的工作表明，患有 AD 的吸烟者有反应 VLNCC 减少卷烟需求和其他成瘾措施。然而，烟草市场 条件可能会对减少卷烟尼古丁政策的有效性产生相当大的影响。 在下一个资助期间，我们将利用行为经济学和行为经济学的原理和方法 药理学检查 VLNCC 对患有 AD 的吸烟者的影响，无论是单独使用还是同时提供替代品 尼古丁的非燃烧来源（电子烟）。在单独的条件下，电子烟将在烟草中提供 仅口味或有吸引力的个性化口味。本次多站点试验采用四人平行分组、务实的设计。 患有 AD 的每日吸烟者将被随机分配到 16 周：(1) 单独吸正常尼古丁含量香烟 (NNCC)， 对照条件，(2) 单独 VLNCC，(3) VLNCC + 烟碱化烟草味（TF 电子烟），或 (4) VLNCC + 含烟碱、首选口味的电子烟（PF 电子烟）。结果衡量包括 CPD、产品需求、渴望、 上诉、精神症状、脑功能生物标志物以及烟草毒物暴露和 气道炎症。使用 16 周后，参与者将接受禁欲评估，其中我们 检查研究条件对参与者戒烟能力及其反应的影响 禁欲。 TCORS 的综合主题是弱势群体。拟议的研究高度 与 CTP 成瘾和行为的科学领域相关，因为它将检查是否减少 香烟中的尼古丁含量会降低香烟的使用、依赖性和产品吸引力，以及这些影响是否 电子烟的普及增强了这一点。它将通过评估健康影响领域 这些条件对大脑功能、烟草毒物暴露和气道炎症的生物标志物的影响。 拟议的研究具有重要意义和创新性，因为它将模拟电子烟的可用性和吸引力 可能会在未充分研究的情况下缓和国家卷烟尼古丁减少政策的有效性 人口。最后，它是有计划的，因为它将建立在我们当前完成的工作的基础上 资助期限。总体而言，该提案有可能继续开展高产的多学科研究 计划并将向 FDA 提供与其监管相关的极其重要的经验证据 责任。