Neurocognitive Profile of Nicotine Use & Withdrawal

描述（由申请人提供）：烟草依赖是美国最常见的药物滥用障碍，也是可预防的主要死因。全世界每年有300多万人因吸烟而丧生。神经认知功能的改变在尼古丁使用和成瘾中起着重要作用，并对治疗效果和康复产生重大影响。神经认知功能下降，可能与潜在的合并症有关，可能导致尼古丁（和类似药物）使用，并阻止成功戒烟。更好地了解使个人处于吸毒风险的神经认知功能障碍以及戒断和康复期间发生的神经认知功能改变可以显着改善治疗结果。拟议的I期研究的主要目标是应用一种创新的神经认知评估方法，警觉性和记忆分析仪（AMP），以评估尼古丁给药和尼古丁剥夺后的26名吸烟者。AMP结果将与之前从健康受试者和睡眠障碍患者中获得的数据进行比较。AMP系统独特地将神经生理学、神经心理学、行为和主观测量整合到易于管理的2小时方案中。AMP旨在提供一种全面的神经认知评估方法，应用于神经病学、精神病学、流行病学和睡眠医学，以进行诊断，并评估药物和其他干预措施的疗效。选择尼古丁作为AMP评价的第一种药物有几个原因：1）使用和成瘾的高流行率，2）现有尼古丁和认知研究的广度和深度，3）尼古丁和尼古丁激动剂治疗应用的未来潜力，以及4）研究人员观察到吸烟在未经治疗的睡眠障碍患者中更普遍。第二阶段的计划包括尼古丁剂量反应研究和其他药物的调查，特别是酒精，咖啡因和莫达法尼（一种目前用于睡眠药物的新型精神兴奋剂）。受试者人群将扩展至包括非吸烟者和睡眠障碍患者。

DESCRIPTION (provided by applicant): Tobacco dependence is the most common substance abuse disorder and the leading preventable cause of death in the United States. More than three million lives a year worldwide are lost due to smoking. Alterations in neurocognitive function play a major role in nicotine use and addiction and have a significant impact on treatment efficacy and rehabilitation. Diminished neurocognitive function, perhaps associated with underlying comorbidity, may lead to nicotine (and similar drug) use and prevent successful smoking cessation. A better understanding of the neurocognitive dysfunctions that put individuals at risk for drug use and the alterations in neurocognitive function that occur during withdrawal and rehabilitation could significantly improve treatment outcomes. The primary goal of the proposed Phase I research is to apply an innovative neurocognitive assessment method, the alertness and memory profiler (AMP) to evaluate 26 smokers following nicotine administration and nicotine deprivation. The AMP results will be evaluated in comparison to data previously acquired from healthy subjects and patients with sleep disorders. The AMP system uniquely integrates neurophysiological, neuropsychological, behavioral and subjective measures into an easy-to-administer, 2-hour protocol. The AMP is being designed to provide a comprehensive neurocognitive assessment method with applications in neurology, psychiatry, epidemiology and sleep medicine for diagnosis and to evaluate the efficacy of pharmaceutical and other interventions. Nicotine was selected as the first drug to be evaluated with the AMP for several reasons: 1) the high prevalence of use and addiction, 2) the breadth and depth of existing research on nicotine and cognition, 3) the future potential for therapeutic applications of nicotine and nicotine agonists, and 4) the investigators observations that smoking was more prevalent among patients with untreated sleep disorders. Plans for the Phase II proposal include nicotine dose-response studies and investigations of additional drugs, specifically alcohol, caffeine and modafanil (a novel psychostimulant currently used in sleep medicine). The subject populations will be expanded to include non-smokers and patients with sleep-disorders.