Pre-Cessation Effects of Bupropion on Smoking

描述(由申请人提供)：在临床试验中，安非他酮被证明可以使长期戒烟率增加一倍。尽管如此，大多数使用安非他酮的吸烟者在戒烟的头几周内又会重新吸烟。安非他酮被假设在典型的1周戒烟前治疗阶段通过减少吸烟的增强效应来帮助吸烟者戒烟。学习理论和之前的基础人类和动物研究支持这样的假设，即在目标戒烟日期(TQD)之前接受安非他酮治疗的时间越长，吸烟满意度和戒烟前每天吸烟数量的下降幅度就越大，戒烟后继续戒烟的比例也越高。这项拟议的研究是我们知道的第一项研究，它系统地改变吸烟者安非他酮治疗的戒烟前持续时间，以检验这些预测。采用两组随机实验设计。100名有戒烟动机的男性和女性吸烟者将被随机分为短期磨合组(服用3周的安慰剂，然后是典型的TQD前1周的安非他明)和长期磨合组(TQD前的4周安非他明)。两组都将接受TQD后7周的安非他酮治疗，以及戒烟的集体行为咨询。在戒烟前治疗阶段，我们预测与安慰剂相比，安非他酮将减少每天吸烟的数量和吸烟满意度。在戒烟后的3个月内，我们预测那些在戒烟前吸烟率和满意度下降最大的人的复吸率将会更低。我们将对延长磨合组的受试者是否比短暂磨合组的受试者停止更多，以及这种影响是否由安非他酮戒断前效果的差异介导进行探索性分析。这项以理论为基础的研究可能导致安非他酮的强化治疗，并更广泛地刺激程序性的基础和临床研究，通过更好地了解药物戒烟所涉及的学习和行为过程来改善癌症控制。

DESCRIPTION (provided by applicant): In clinical trials bupropion has been shown to double long-term smoking cessation rates. Nevertheless, most smokers using bupropion relapse back to smoking within the first few weeks of cessation. Bupropion has been hypothesized to help smokers to quit in part by reducing the reinforcing effects of smoking during the typical 1-week pre-quitting treatment phase. Learning theory and previous basic human and animal research support the hypothesis that a longer duration of bupropion treatment prior to the target quit date (TQD) will yield greater decreases in smoking satisfaction and the number of cigarettes smoked per day before quitting, and higher rates of continuous cessation after quitting. The proposed research is the first study of which we are aware to systematically vary the pre-quitting duration of bupropion treatment in smokers to test these predictions. A two group randomized experimental design will be used. One hundred male and female smokers who are motivated to quit smoking will be randomized to a brief run-in group (3 weeks of placebo, followed by the typical 1 week of pre-TQD bupropion) and an extended run-in group (4 weeks of pre-TQD bupropion). Both groups will receive 7 weeks of post-TQD bupropion, as well as group behavioral counseling for smoking cessation. During the pre-quitting treatment phase we predict that bupropion will reduce the number of cigarettes smoked daily and smoking satisfaction, relative to placebo. During a 3-month post-quitting phase, we predict that relapse will be lower in those who experience the greatest pre-quit reductions in smoking rate and satisfaction. We will conduct exploratory analyses of whether cessation is greater for subjects in the extended run-in group compared to the brief run-in group, and whether this effect is mediated by differences in the pre-quit effects of bupropion. This theory-based research may lead to enhanced treatment with bupropion and more broadly stimulate programmatic basic and clinical studies that improve cancer control through a better understanding of learning and behavioral processes implicated in pharmacotherapy for tobacco cessation.