A Clinical Trial of Two Medications on Smoking Cessation

描述(由申请人提供)：吸烟对健康构成严重但可预防的危害。即使吸烟的有害影响是 众所周知，吸烟在美国的流行率仍然很高， 特别是对于年轻人、社会经济地位较低的人，以及 少数群体。虽然有些人是自己戒烟或与烟民一起戒烟 帮助戒烟的行为干预，有实质性的 无法戒烟或重新吸烟的吸烟者人数 戒烟药物疗法的辅助。目前，有以下几种 两种药物疗法(尼古丁替代疗法和 缓释安非他酮)，是FDA批准用于在 到目前为止，还没有临床试验比较尼古丁的使用 安非他酮贴剂和缓释安非他酮单独或组合，如 低收入、年轻人群戒烟的药物治疗 参与者或少数群体参与者。鉴于以下人群的高复发率 总的来说，尼古丁替代疗法和 安非他酮缓释片可能特别有效。因此，我们 假设尼古丁贴片和尼古丁贴片的使用 安非他酮缓释片与单独使用尼古丁贴片或 单单缓释安非他酮会导致初始和长期的增加 年轻、低收入和少数族裔人群的戒烟率 烟。我们计划在这项双盲临床试验中测试这些假说 将年轻、低收入和少数族裔吸烟者随机分为三组 组：1)尼古丁贴片加安慰剂缓释安非他酮组 2)安非他酮缓释片加安慰剂尼古丁贴片，或第3组) 尼古丁贴片加安非他酮缓释片。我们的主要终端 评估是通过自我报告的戒烟率，并经生物化学验证 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.