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

基本信息

批准号：
10477407
负责人：
STACEY C SIGMON
金额：
$ 67.98万
依托单位：
UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
依托单位国家：
美国
项目类别：
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/10477407
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 Work addiction addiction liability adverse outcome airway inflammation behavioral economics behavioral pharmacology buprenorphine treatment cigarette craving cigarette smoking craving design disadvantaged women 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

项目摘要

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) 患者的吸烟率是美国普通人群的六倍成年人口。吸烟还与该人群的显着发病率和死亡率相关，阿片类药物依赖吸烟者的死亡率是阿片类药物依赖非吸烟者的四倍，戒烟率大约是非药物滥用者的四分之一。降低尼古丁含量的国家政策香烟有可能成为减少吸烟率和吸烟率的有效方法该弱势群体的相关不良健康后果。在普通人群中进行的对照试验吸烟者已经证明，吸烟者改吸尼古丁含量极低 (VLNC) 的香烟会导致每天吸烟量、香烟依赖和烟草毒物暴露的减少，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 OUD 的吸烟者通过减少卷烟需求和其他措施来应对卷烟尼古丁含量的减少成瘾潜力的衡量标准，尽管我们对其他弱势吸烟者群体的程度较小一直在检查。考虑到与吸烟有关的严重差异和不良健康后果在阿片类药物依赖吸烟者群体中，我们认为结合电子烟和优选的调味剂还代表了一组最有可能对可燃物产生最大影响的条件吸烟。因此，在下一个资助期间，我们将利用行为经济学的原理和方法和行为药理学，我们通过检查减少尼古丁的影响来扩展我们的研究卷烟含量对这一弱势群体吸烟的影响，有或没有非替代品燃烧的尼古丁产品（即电子烟）很容易获得。我们还将审查是否上诉非燃烧替代品通过口味得到增强。在多中心、随机临床试验中，我们将使用受试者间、四个平行组的研究设计，旨在评估 VLNC 卷烟对吸烟的影响当前 OUD 吸烟者的比率、依赖严重程度和烟草毒素暴露。参加者将是随机分配到单独接触 (1) 尼古丁含量正常的香烟 16 周，这将作为对照条件，(2) 单独 VLNC 香烟，(3) VLNC + 烟草味尼古丁电子烟，或 (4) VLNC + 带有首选口味的烟碱电子烟。该设计将直接用于 FDA CTP 对可能实施减少尼古丁含量政策的可能市场场景进行建模。全面的，该提案有可能继续开展富有成效的多学科研究计划，重点关注最脆弱和研究最少的烟草使用者群体。该项目将为 FDA CTP 提供与其监管职责相关的极其重要的经验证据，同时也贡献了新的关于减少弱势群体烟草制品成瘾潜力的科学知识。