Low Nicotine Content Cigarettes in Vulnerable Populations: Opioid Abusers

弱势群体中的低尼古丁含量香烟：阿片类药物滥用者

• 批准号: 10247027
• 负责人: STACEY C SIGMON
• 金额: $ 68.47万
• 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/10247027
• 关键词: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol; Abstinence; Address; Adult; Behavior; Biological Markers; Brain; Cerebrovascular Circulation; Cigarette; Cigarette Smoker; Dependence; Economically Deprived Population; Effectiveness; Electronic cigarette; Exhalation; Experimental Models; Exposure to; Flavoring; Funding; General Population; Goals; Health; Individual; Interdisciplinary Study; Knowledge; Measures; Methods; Modeling; Mood Disorders; Morbidity - disease rate; Nicotine; Nitric Oxide; Opiate Addiction; Opioid abuser; Outcome; Outcome Measure; Participant; Policies; Population; Prevalence; Randomized; Randomized Clinical Trials; Research; Research Design; Science; Secondary to; Severities; Site; Smoke; Smoker; Smoking; Smoking Cessation Intervention; Source; Structure; Time; Tobacco; Tobacco-Associated Carcinogen; Toxicant exposure; Toxin; Universities; Vermont; Vulnerable Populations; Withdrawal; Woman; Work; addiction; adverse outcome; airway inflammation; behavioral economics; behavioral pharmacology; buprenorphine treatment; cigarette craving; cigarette smoking; craving; design; electronic cigarette use; innovation; low nicotine content cigarette; methadone treatment; mortality; neuroimaging; non-smoker; opioid use disorder; programs; recruit; reduce tobacco use; response; smoking prevalence; study population; tobacco flavor; tobacco products; tobacco toxicant; tobacco user

Prevalence of smoking among individuals with opioid use disorder (OUD) is six-fold that of the general US adult population. Smoking is also associated with significant morbidity and mortality in this population, with the mortality rate of opioid-dependent smokers four times that of opioid-dependent nonsmokers and quit rates of approximately one-fourth that of non-substance abusers. A national policy of reducing the nicotine content of cigarettes has the potential to be an effective method of reducing the prevalence of smoking and smoking- related adverse health outcomes in this vulnerable population. Controlled trials in the general population of smokers have demonstrated that switching smokers to very low nicotine content (VLNC) cigarettes results in reductions in cigarettes per day, cigarette dependence, and tobacco toxicant exposure, with few adverse consequences. Furthermore, our work during the current funding period indicates that smokers with OUD respond to reductions in the nicotine content of cigarettes with reductions in cigarette demand and other measures of addiction potential, although to a lesser extent that the other vulnerable smoker populations we have been examining. Considering the serious smoking-related disparities and adverse health consequences in the population of opioid-dependent smokers, we believe that an approach that combines e-cigarettes and also preferred flavoring represents a set of conditions most likely to produce a maximal effect on combustible smoking. Thus during the next funding period, we will utilize principles and methods of behavioral economics and behavioral pharmacology as we extend our research by examining the effects of reducing the nicotine content of cigarettes on cigarette smoking in this vulnerable population with and without substitute non- combusted nicotine products (i.e., e-cigarettes) readily available. We will also examine whether appeal of the non-combusted alternative is enhanced by flavors. In a multi-site, randomized clinical trial, we will use a between-subject, four parallel group, research design to evaluate the effects of VLNC cigarettes on smoking rate, dependence severity, and tobacco toxin exposure in smokers with current OUD. Participants will be randomly assigned to 16 weeks of exposure to (1) normal nicotine content cigarettes alone, which will serve as the control condition, (2) VLNC cigarettes alone, (3) VLNCs + tobacco-flavored nicotinized e-cigarettes, or (4) VLNCs + nicotinized e-cigarette with preferred flavoring. This design will be of direct utility to the FDA CTP by modeling possible market scenarios in which a reduced nicotine content policy may be implemented. Overall, this proposal has the potential to continue a productive multidisciplinary research program that focuses on the most vulnerable and least studied populations of tobacco users. This project will provide FDA CTP with critically important empirical evidence relevant to its regulatory responsibilities, while also contributing new scientific knowledge on reducing the addiction potential of tobacco products in vulnerable populations.

阿片类药物使用障碍(OUD)患者的吸烟率是普通美国人的6倍 成年人口。在这一人群中，吸烟也与显著的发病率和死亡率有关， 阿片依赖吸烟者的死亡率是阿片依赖非吸烟者的四倍，戒烟率 大约是非物质滥用者的四分之一。一项降低烟草中尼古丁含量的国家政策 香烟有可能成为降低吸烟和吸烟流行率的有效方法- 在这一弱势群体中出现相关的不良健康后果。在普通人群中进行的对照试验 吸烟者已经证明，将吸烟者换成尼古丁含量极低(VLNC)的香烟会导致 减少每天吸烟、香烟依赖和烟草毒物暴露，几乎没有不良反应 后果。此外，我们在当前资助期内的工作表明，吸烟者患有OUD 应对卷烟尼古丁含量的减少，减少卷烟需求和其他 对成瘾潜力的衡量，尽管在较小程度上其他易受伤害的吸烟者群体 一直在检查。考虑到与吸烟有关的严重差距和不利的健康后果 在阿片依赖吸烟者中，我们认为将电子烟和 此外，首选调味料代表了一组最有可能对可燃物质产生最大影响的条件 抽烟。因此，在下一个资助期，我们将利用行为经济学的原理和方法 和行为药理学，因为我们通过检查减少尼古丁的影响来扩展我们的研究 吸烟对易感人群香烟含量的影响 燃烧的尼古丁产品(即电子烟)随处可得。我们亦会研究有关上诉是否会 非燃烧的替代品通过口味得到了增强。在一项多点随机临床试验中，我们将使用 受试者之间，四个平行小组，评估VLNC香烟对吸烟影响的研究设计 吸烟者的吸烟率、依赖程度和烟草毒素暴露。参与者将是 随机分配到暴露于(1)正常尼古丁含量香烟的16周，这将作为 控制条件，(2)仅VLNC香烟，(3)VLNC+烟草味尼古丁电子烟，或(4) VLNCs+尼古丁电子烟，首选香料。该设计将通过以下方式对FDA CTP直接有用 对可能实施减少尼古丁含量政策的市场情景进行建模。总的来说， 这项提议有可能继续一个富有成效的多学科研究计划，重点是 最易受伤害和研究最少的烟草使用者群体。该项目将为FDA CTP提供 与其监管责任相关的至关重要的经验证据，同时也贡献了新的 减少易受伤害人群中烟草制品成瘾潜力的科学知识。