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

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

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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）中吸烟的患病率是美国一般的六倍成人人口。吸烟还与该人群的发病率和死亡率显着有关，阿片类吸烟者的死亡率四倍，阿片类药物依赖性非吸烟者的死亡率和退出率大约四分之一的非遗产滥用者。减少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个脆弱人群中，相关的不良健康结果。一般人口的对照试验吸烟者已经证明，将吸烟者转向非常低的尼古丁含量（VLNC）香烟会导致每天减少香烟，香烟依赖和烟草有毒物质暴露，几乎不利结果。此外，我们在当前资金期间的工作表明吸烟者有Oud 响应减少香烟的尼古丁含量，并减少了香烟需求和其他成瘾潜力的衡量标准，尽管在较小程度上，其他脆弱的吸烟者种群我们一直在检查。考虑到与吸烟有关的严重差异和不利的健康后果在依赖阿片类药物的吸烟者的人群中，我们认为一种结合电子烟和的方法还首选的调味料代表了一组最有可能对可燃作用产生最大作用吸烟。因此，在下一个资金期间，我们将利用行为经济学的原则和方法通过检查减少尼古丁的效果扩展研究的行为药理学和行为药理学在这个脆弱人群中吸烟的香烟含量，有或没有替代非替代品容易获得燃烧的尼古丁产品（即电子烟）。我们还将研究是否上诉非燃烧的替代品可通过口味增强。在多站点的随机临床试验中，我们将使用受试者间，四个平行组，研究设计设计，以评估VLNC香烟对吸烟的影响当前OUD的吸烟者中的率，依赖性严重程度和烟草毒素暴露。参与者会仅将其随机分配给16周的暴露于（1）普通尼古丁含量香烟，这将作为控制条件，（2）单独使用VLNC香烟，（3）VLNC +烟草味的烟素电子烟，或（4） VLNC +具有首选调味料的烟碱化电子烟。该设计将直接实用到FDA CTP 建模可能实施减少尼古丁内容政策的可能的市场情况。全面的，该建议有可能继续一项富有成效的多学科研究计划，该计划的重点是最脆弱和研究最少的烟草用户人群。该项目将为FDA CTP提供至关重要的经验证据与其监管责任有关，同时也贡献了新的关于降低弱势群体中烟草产品成瘾潜力的科学知识。