A Clinical Trial of Two Medications on Smoking Cessation

描述（由申请人提供）：吸烟造成严重的，但 可预防的健康风险。即使吸烟的有害影响是 众所周知，在美国吸烟的流行率仍然很高， 特别是年轻人、社会经济地位较低的人， 少数群体。虽然有些人戒烟自己或与 在行为戒烟干预的帮助下， 未能戒烟或复吸而又未能戒烟的吸烟者人数 药物治疗对戒烟的帮助。目前有 两种类型的药物治疗（尼古丁替代疗法和 缓释安非他酮），FDA批准用于戒烟， 到目前为止，还没有临床试验比较尼古丁的使用 贴剂和缓释安非他酮，单独或组合， 低收入年轻人戒烟的药物治疗 参与者或少数参与者。鉴于高复发率， 一般来说，这些组的尼古丁替代疗法和 缓释安非他酮可能特别有效。所以我们 假设使用尼古丁贴片和 与单独使用尼古丁贴片相比，缓释安非他酮或 单独使用缓释安非他酮将导致初始和长期 年轻低收入和少数民族的长期戒烟率， 抽烟我们计划在这项双盲临床试验中测试这些假设， 将吸烟的年轻人、低收入者和少数民族随机分为三组， 组：组1）尼古丁贴剂+安慰剂缓释安非他酮，组 2)缓释安非他酮+安慰剂尼古丁贴剂，或第3组） 尼古丁贴片加缓释安非他酮。我们的主要终点 评估是通过生物化学验证的自我报告戒烟率 在三个治疗组之间的不同时间点进行验证。

DESCRIPTION (provided by applicant): Cigarette smoking poses a serious but preventable health risk. Even though the detrimental effects of smoking are well known, the prevalence of cigarette smoking remains high in the U.S., particularly for younger persons, persons of lower socioeconomic status, and minority groups. Although some persons quit smoking on their own or with the help of behavioral smoking cessation interventions, there are a substantial number of smokers who are unable to quit smoking or relapse to smoking without the aid of pharmacologic therapy for smoking cessation. Currently, there are two types of pharmacologic therapies (Nicotine Replacement Therapy and Sustained-release bupropion) that are FDA approved for smoking cessation in the U.S. To date, there has been no clinical trial comparing use of the nicotine patch and sustained-release bupropion, alone or in combination, as pharmacologic therapy for smoking cessation among low income, younger participants or in minority participants. Given the high relapse rates among these groups in general, the combination of nicotine replacement therapy and sustained-release bupropion may be particularly efficacious. Therefore, we hypothesize that use of a combination of the nicotine patch and sustained-release bupropion as compared to use of the nicotine patch alone or to sustained-release bupropion alone will result in increased initial and long term rates of smoking cessation in younger low income and minority persons who smoke. We plan to test these hypotheses in this double blind clinical trial by randomizing younger, low income and minority persons who smoke to one of three groups: Group 1) Nicotine patch plus placebo sustained-release bupropion, Group 2) Sustained-release bupropion plus placebo nicotine patch, or Group 3) Nicotine patch plus sustained-release bupropion. Our primary endpoint assessment is smoking cessation rates by self-report verified by biochemical validation at different time points between the three treatment groups.