PREVENTION OF CIGARETTE SMOKING IN ADHD YOUTH

（申请人的描述）毫无疑问，香烟 吸烟是发病和过早发病的重要原因， 美国的 每年，吸烟导致大约30至40 冠心病死亡率的10%和癌症死亡率的30% 每年有近50万人死亡。 但尽管 这些统计数字，全国有五千四百多万烟民。 其中400万是青少年，3,000多名青少年开始吸烟 每一天. 如果青少年吸烟的比例继续下去， 社会将是巨大的。 吸烟在年轻人中已经变得如此普遍， 被食品和药物管理局视为“儿科疾病”。 研究表明，大多数成年人可以避免成为 烟草使用者，如果他们能保持在青少年时期戒烟。 这一发现表明，预防工作的重点是青春期， 开始吸烟的已知风险期。 该提案旨在应用精神药理学高风险范例 防止青少年经常吸烟和尼古丁依赖。 的 工作有三个创新特点：1）使用流行病学数据， 确定一组青少年吸烟的高风险; 2）使用 戒烟药物，也解决了临床特征的 3）实施程序，以促进 对研究参与者进行长期跟踪。 这些特征 这是由我们提案的三个主要目标所界定的。 先前的研究表明，注意力缺陷多动的儿童 注意力缺陷多动障碍（ADHD），谁也有共病行为，情绪或焦虑 这些疾病是经常吸烟和尼古丁依赖的高风险。 因此，我们的第一个目标是招募一群这样的青少年， 预防性治疗方案，在他们开始定期 smoking. 我们的第二个目标是完成一项双盲临床试验 安非他酮用于预防高危ADHD患者吸烟 青少年。 安非他酮是这一组的适当药物， 有几个原因。 它对治疗抑郁症有效， 高危人群中最常见的共病疾病。 此外，委员会认为， 先前的研究还表明，它可以减少ADHD症状， 有效的戒烟治疗。 此外，其假定 作用机制影响神经系统，被认为是介导ADHD和 和吸烟。 除了这些主要目标外，我们还将评估 安非他酮对多动症和抑郁症的症状，并将实施 这将使我们能够研究这个样本的结果， 今后的建议，如果有必要的话。 我们将采用平衡、双盲、安慰剂对照研究设计。 65名高危青少年将接受安慰剂治疗， 安非他酮 受试者将在3个月内招募， 根据他们被招募的时间， 书房 这项研究的设计是为了使每名受试者都有 至少一年的随访数据。 有些科目将有多达 3.5多年的跟踪数据。 使用药理学试剂，如安非他酮，尚未被证实。 在预防吸烟方面进行了探索。 因为这种药物 已被用于治疗多动症和吸烟，它 可以帮助预防吸烟在这个高风险的 人口 本可以预防的病例数量不少。 据估计，全球有350万儿童患有多动症， 已经被证明是吸烟者，针对这一群体可能有可能 影响70万儿童和青少年。

DESCRIPTION: (Applicant's Description) There is no doubt that cigarette smoking is a substantial source of morbidity and premature morbidity the United States. Each year, cigarette smoking causes about 30 to 40 percent of coronary heart disease deaths and 30 percent of cancer deaths, leading to nearly half a million deaths each year. Yet, despite these statistics, there are more than 54 million smokers in the nation. Four million of these are adolescents and over 3,000 youth start smoking each day. If these rates of teenage smoking continue, the costs to society will be enormous. Cigarette smoking has become so widespread in youth that it is considered a "pediatric disease" by the Food and Drug Administration. Studies suggest that most adults could be prevented from becoming tobacco users if they could be kept tobacco-free during adolescence. This finding suggests that preventive efforts focus on adolescence, a known risk period for the initiation of smoking. This proposal seeks to apply a psychopharmacologic high risk paradigm to prevent regular smoking and nicotine dependence in adolescence. The work has three innovative features: 1) use of epidemiologic data to define a group of adolescents at high risk for smoking; 2) use of an anti-smoking medication that also addresses clinical features of the high-risk group and 3) implementation of procedure to facilitate the long-term follow-up of research participants. These features are defined by the three main aims of our proposal. Prior work shows that children with attention deficit hyperactivity disorder (ADHD), who also have comorbid conduct, mood or anxiety disorders, are at high risk for regular smoking and nicotine dependence. Thus, our first aim is to recruit a group of these adolescents into a preventative treatment protocol, before they have initiated regular smoking. Our second aim is to complete a double-blind clinical trial of bupropion for the prevention of smoking in high-risk ADHD adolescents. Bupropion is an appropriate agent for this group for several reasons. It is efficacious for the treatment of depression, one of the most common comorbid disorders in the high risk group. Moreover, prior research also shows that it reduces ADHD symptoms and is an effective treatment for smoking cessation. Moreover, its putative mechanism of action affects neural systems believed to mediate both ADHD and smoking. In addition to these main aims, we will assess the effects of bupropion on symptoms of ADHD and depression and will implement procedures that will allow us to study the outcome of this sample in future proposals, should that be warranted. We will use a balanced, double-blind, placebo-controlled study design. Sixty-five high risk adolescents will be given placebo and sixty-five bupropion. Subjects will he recruited over a 3-month period and will have varying lengths of follow-up based on when they were recruited into the study. The study is designed so that each subject will have at least one year of follow-up data. Some subjects will have as much as 3.5 years of follow-up data. The use of pharmacological agents, such as Bupropion, have not been explored in the prevention of cigarette smoking. Since this medication has been used for both the treatment of ADHD and cigarette smoking, it could aid in the prevention of cigarette smoking in this high-risk population. The number of cases that could he prevented is not trivial. Since there are estimated to be 3.5 million children with ADHD and 20% have been shown to be smokers, targeting this group could potentially impact 700,000 children and adolescents.