NRT & Bupropion Mechanisms of Efficacy in Smokers

描述(由申请人提供)：这项修订建议的第一个目标是准确评估3个不同治疗组在66天内戒烟症状和相关生物行为指标的持续时间和轨迹：1)安非他酮SR(BIJP)，2)经皮尼古丁贴片(TNP)，3)安慰剂。通过使用旨在最大限度地减少禁欲和最大限度地减少研究辍学的程序，将最大限度地提高研究的敏感性和准确性。第二个目标是描述BUP和TNP促进禁欲的大脑和心理机制。虽然BUP和TNP在促进戒烟方面的有效性已被反复证明，但对调节这种有效性的机制知之甚少。这一竞争性持续方案的最终主要目标是表征心理和大脑机制的个体差异，这些机制介导了BUP和TNP对吸烟戒断和戒断症状的有益影响。第二个目标是评估一组创新的大脑以及注意力和情感的生物行为指标预测复发的能力。 为了实现这些目标，将在66天的戒烟时间内对戒烟效果进行集中评估，包括情绪、警觉性、对吸烟和情绪刺激的注意偏差以及相关的生理指标(静息状态和情绪特征的EEC激活和激活不对称指数，以及情绪和吸烟刺激引发的事件相关电位活动)。吸烟者将被随机分配到三个立即戒烟组中的一个(每组80人)：(1)安非他酮+安慰剂贴片(2)安慰剂药丸或尼古丁贴片；(3)安慰剂药片+安慰剂贴片或第四(对照组)组(N=60)，将在最后的实验阶段(其他受试者完成66天戒烟期后)后戒烟。3个治疗组的受试者和对照组的受试者将在相同的时间点在实验期间接受相同的生物行为测量评估。据推测，BUF和TNP将具有共同和独特的机制，通过它们来减少戒断症状，性别和个性特征将缓和这些治疗的效果。(注：*为了避免最后一节课的情绪和唤醒效应，受试者实际上将戒烟67天，但生物行为测量将在禁欲的第66天收集

DESCRIPTION (provided by applicant): The first aim of this revised proposal is to accurately assess the duration and trajectories of smoking abstinence symptoms and associated biobehavioral indices across 66 days of quitting smoking in 3 different treatment groups: 1) bupropion SR (BIJP), 2) transdermal nicotine patch (TNP), and 3) a placebo. Study sensitivity and accuracy will be maximized by using procedures designed to maximize abstinence and minimize study dropout. The second aim is to characterize brain and psychological mechanisms by which BUP and TNP promote abstinence. While the efficacies of BUP and TNP in promoting smoking abstinence have been repeatedly demonstrated little is known about the mechanisms mediating this efficacy. The final primary goal of this competitive continuation proposal is to characterize individual differences in psychological and brain mechanisms mediating the beneficial effects of BUP and TNP on smoking abstinence and withdrawal symptoms. A secondary goal is to assess the ability of a battery of innovative brain and biobehavioral measures of attention and affect to predict relapse. To achieve these goals the effects of quitting smoking with or without the help of TNP and BUP will be assessed intensively across 66 days of abstinence, Dependent measures will be mood, vigilance, attentional bias to smoking and emotional stimuli, and related physiological measures (resting EEC activation and activation asymmetry indices of affective states and traits, and event-related potential activity elicited by emotional and smoking stimuli). Smokers will be randomly assigned to one of three immediate-quit groups (N = 80 per group): (1) bupropion + placebo patch (2) placebo pill ¿ nicotine patch, and (3) placebo pill + placebo patch or to a fourth (control) group (N = 60) that will quit after the final experimental session (after the other subjects have completed their 66-day abstinence period). Subjects in the 3 treatment groups and the control group will have the same set of biobehavioral measures assessed during the experimental sessions at the same points in time. It is hypothesized that BUF and TNP will have both common and unique mechanisms by which they reduce withdrawal symptoms and that gender and personality traits will moderate the effects of these treatments. (Note,* To avoid final-session mood and arousal effects subjects will actually quit for 67 days, but biobehavioral measures will be collected on the 66 day of abstinence