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: 9328042
• 负责人: Stephen T Higgins
• 金额: $ 82.34万
• 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/9328042
• 关键词: Abstinence; Acute; Address; Adherence; Area; Behavioral; Biological Markers; Cigarette; Cognition; Comorbidity; Cotinine; Exposure to; Family Smoking Prevention and Tobacco Control Act; Funding; General Population; Goals; Health; Health Policy; Impaired cognition; Literature; Lung; Major Depressive Disorder; Measures; Mental Depression; Mental disorders; Methods; Morbidity - disease rate; Neurocognitive; Nicotine; Nicotine Dependence; Nicotine Withdrawal; Outcome; Participant; Pattern; Phase; Policies; Population; Principal Investigator; Public Health; Randomized; Randomized Clinical Trials; Reporting; Risk Marker; Severities; Smoke; Smoker; Smoking; Testing; Tobacco; Tobacco use; Tobacco-Associated Carcinogen; Toxicant exposure; United States; United States Food and Drug Administration; Vermont; Vulnerable Populations; Withdrawal; authority; behavioral economics; cardiovascular risk factor; cigarette smoking; cognitive function; cognitive performance; cost; craving; depressive symptoms; design; experience; innovation; mortality; preference; psychiatric symptom; response; smoking prevalence; tobacco regulatory science; toxicant; trial design

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精神病患者吸食的。 将香烟的尼古丁含量降低到非成瘾水平（即，< 0.2毫克尼古丁）是一种创新的 制定可大幅降低烟草相关发病率和死亡率的监管战略。但安 专家小组评估了这项政策的潜在影响，确定了意外的可能性。 吸烟者与共病精神疾病的后果作为一个关键领域的关注，因为这些吸烟者 也可能对香烟中尼古丁含量的减少做出反应， 以及补偿性吸烟。需要考虑的一个重要共病人群是当前吸烟者 重度抑郁症（MDD），占目前尼古丁依赖人群的20-30%。小 据我们所知，尼古丁减少政策可能对患有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 暴露、香烟耐受性或抑郁严重程度。文献中的这一重大空白 将在拟议的项目中予以解决。在研究1中，参与者将评估四支香烟的急性影响， 不同尼古丁产量（0.83，0.28，0.10，0.03毫克）的条件下对渴望，尼古丁戒断， 当可用时，降低尼古丁香烟替代正常尼古丁香烟的程度 后者受到限制。在研究2中，在1周2阶段基线评估期后， 目前的MDD将被随机分配到这四个相同的香烟条件之一，为期12周， 暴露阶段。在基线和延长暴露阶段，烟草使用模式， 将评估毒物暴露、精神症状、认知能力和吸烟状况。 通过研究低尼古丁香烟的潜在积极和消极后果， 吸烟者与MDD，这项研究将探讨是否有一个监管的方法，减少尼古丁含量的 将香烟降至不上瘾的水平是减少这一人群吸烟的可行方法。 相关性（参见说明）： 吸烟率异常高，与吸烟有关的 吸烟者抑郁症的发病率和死亡率。该项目将调查急性和 尼古丁含量极低的香烟对吸烟、毒物、精神症状 认知功能和其他措施的吸烟者与严重抑郁症。这些信息将 帮助确定将香烟尼古丁含量限制在极低水平的公共卫生政策是否 对这些吸烟者来说是有效和安全的。