Project 3: Low Nicotine Content Cigarettes in Vulnerable Populations: p289-358

项目 3：弱势群体中的低尼古丁含量香烟：p289-358

• 批准号: 8593367
• 负责人: Stephen T Higgins
• 金额: $ 84.98万
• 依托单位: UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8593367
• 关键词: Abstinence; Acute; Address; Adherence; Area; Behavioral; Biological Markers; Cigarette; Clinical Trials Design; Cognition; Cotinine; Economics; Exposure to; Family Smoking Prevention and Tobacco Control Act; Funding; General Population; Goals; Health; Health Policy; Impaired cognition; Instruction; Literature; Lung; Major Depressive Disorder; Measures; Mental Depression; Methods; Morbidity - disease rate; Neurobehavioral Manifestations; Neurocognitive; Nicotine; Nicotine Dependence; Nicotine Withdrawal; Outcome; Participant; Pattern; Performance; Phase; Policies; Population; Principal Investigator; Public Health; Randomized; Randomized Clinical Trials; Reporting; Risk Marker; Science; Severities; Smoke; Smoker; Smoking; Symptoms; Testing; Tobacco; Tobacco use; Tobacco-Associated Carcinogen; Toxicant exposure; United States; United States Food and Drug Administration; Vermont; Vulnerable Populations; Withdrawal; authority; cardiovascular risk factor; cigarette smoking; cognitive function; cost; craving; depressive symptoms; design; experience; innovation; mortality; preference; response; smoking prevalence; toxicant

Nearly half of the tobacco consumed in the United States is smoked by people with psychiatric illness. Reducing the nicotine content of cigarettes to a non-addictive level {i.e., < 0.2 mg nicotine) is an innovative regulatory strategy that could significantly reduce tobacco-related morbidity and mortality. However, an expert panel that evaluated the potential impact of this policy identified the possibility of unintended consequences for smokers with comorbid psychiatric illness as a key area of concern, as these smokers could also respond to reductions in the nicotine content of cigarettes with increases in psychiatric symptoms and with compensatory smoking. One important comorbid population to consider is smokers with current major depressive disorder (MDD), who comprise 20-30% of people with current nicotine dependence. Little is known about the effects a nicotine reduction policy might have on smokers with MDD, as to our knowledge no studies have reported the effects of very low nicotine content cigarettes on smoking rate, toxicant exposure, cigarette tolerability or depression severity in these smokers. This substantial gap in the literature will be addressed in the proposed project. In Study 1, participants will assess acute effects of four cigarette conditions of varying nicotine yield (0.83, 0.28, 0.10, 0.03 mg) on craving, nicotine withdrawal, and the degree to which the reduced-nicotine cigarettes substitute for normal-nicotine cigarettes when availability of the latter is constrained. In Study 2, after a 1-week, 2-session baseline assessment period, smokers with current MDD will be randomized to one of these same four cigarette conditions for a 12-week extended exposure phase. Over the baseline and extended-exposure phases, patterns of tobacco use, biomarkers of toxicant exposure, psychiatric symptoms, cognitive performance and smoking topography will be assessed. By examining both the potential positive and negative consequences of very low nicotine cigarette use in smokers with MDD, this study will examine whether a regulatory approach of reducing the nicotine content of cigarettes to a non-addictive level is a viable method of reducing smoking in this population. RELEVANCE (See instructions): There is an unusually high rate of cigarette smoking and correspondingly high rates of smoking-related morbidity and mortality in smokers with major depressive disorder. This project will investigate the acute and extended effects of very low nicotine content cigarettes on smoking, toxicants, psychiatric symptoms, cognitive functioning and other measures in smokers with major depressive disorder. This information will help to determine whether a public health policy of limiting the nicotine content of cigarettes to very low levels would be effective and safe for these smokers.

在美国，近一半的烟草消费是由患有精神疾病的人吸烟的。 将香烟中的尼古丁含量降低到不会上瘾的水平(即0.2毫克尼古丁)是一种创新 可显著降低与烟草有关的发病率和死亡率的监管战略。然而，一个 评估这一政策的潜在影响的专家小组确定了意外的可能性 对患有共病精神疾病的吸烟者的后果是一个关键的关切领域，因为这些吸烟者 也可以对香烟中尼古丁含量的减少和精神症状的增加做出反应 还有补偿性吸烟。需要考虑的一个重要的共病人群是吸烟者 严重抑郁障碍(MDD)，占目前尼古丁依赖者的20%-30%。一点儿 据我们所知，尼古丁减少政策可能会对患有MDD的吸烟者产生影响 没有研究报道尼古丁含量极低的香烟对吸烟率、有毒物质的影响 这些吸烟者的暴露、对香烟的耐受性或抑郁严重程度。文学作品中的这一巨大差距 将在拟议的项目中得到解决。在研究1中，参与者将评估四种香烟的急性影响 不同的尼古丁产量(0.83，0.28，0.10，0.03毫克)在渴望，尼古丁戒断，和 在以下情况下，降低尼古丁香烟取代正常尼古丁香烟的程度 后者是受约束的。在研究2中，在为期一周、两次会议的基线评估期之后，吸烟者 目前的MDD将随机分配到这四种相同的香烟条件中的一种，延长12周 曝光阶段。在基线和长期接触阶段，烟草使用模式，生物标志物 将对毒物暴露、精神症状、认知能力和吸烟情况进行评估。 通过研究极低尼古丁香烟使用的潜在积极和消极后果 对于患有MDD的吸烟者，这项研究将检查减少尼古丁含量的监管方法 在这一人群中，减少吸烟的可行方法是将香烟降到不会上瘾的水平。 相关性(请参阅说明)： 吸烟率异常高，相应地，与吸烟相关的比率也很高 患有严重抑郁障碍的吸烟者的发病率和死亡率。该项目将调查急性和非传染性疾病 尼古丁含量极低的香烟对吸烟、有毒物质、精神症状、 患有严重抑郁障碍的吸烟者的认知功能和其他测量。此信息将 帮助确定将香烟的尼古丁含量限制在很低水平的公共卫生政策 对于这些吸烟者来说，水平将是有效和安全的。