A Clinical Trial of Two Medications on Smoking Cessation

两种戒烟药物的临床试验

• 批准号: 6430710
• 负责人: KAREN C JOHNSON
• 金额: $ 49.55万
• 依托单位: UNIVERSITY OF TENNESSEE HEALTH SCI CTR
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-01-07 至 2006-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6430710
• 关键词: antidepressants; behavior therapy; breath tests; bupropion; clinical trials; combination chemotherapy; depression; drug /alcohol abstinence; drug detection; drug withdrawal; ethnic group; human subject; human therapy evaluation; low socioeconomic status; nicotine replacement; patient oriented research; questionnaires; relapse /recurrence; smoking; smoking cessation; substance abuse related behavior; therapy adverse effect; tobacco abuse; young adult human (21-34)

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.

描述（由申请人提供）：吸烟会造成严重但可预防的健康风险。尽管吸烟的危害是 众所周知，美国的吸烟率仍然很高， 特别是对于年轻人、社会经济地位较低的人，以及 少数群体。尽管有些人自行戒烟或通过戒烟 在行为戒烟干预措施的帮助下，有大量的 无法戒烟或重新吸烟的吸烟者人数 借助药物治疗戒烟。目前，有 两种类型的药物疗法（尼古丁替代疗法和 缓释安非他酮）经 FDA 批准用于戒烟 迄今为止，美国还没有比较尼古丁使用的临床试验 贴剂和缓释安非他酮，单独或组合，如 低收入年轻人戒烟的药物治疗 参与者或少数参与者。鉴于其中的高复发率 一般来说，这些群体结合尼古丁替代疗法和 缓释安非他酮可能特别有效。因此，我们 假设结合使用尼古丁贴片和 缓释安非他酮与单独使用尼古丁贴片或 单独缓释安非他酮会导致初始和长期 较年轻的低收入人群和少数族裔的长期戒烟率 抽烟。我们计划在这项双盲临床试验中测试这些假设 将年轻、低收入和少数族裔吸烟者随机分为三组之一 组别：第 1 组）尼古丁贴片加安慰剂缓释安非他酮，组 2) 缓释安非他酮加安慰剂尼古丁贴片，或第 3 组) 尼古丁贴片加缓释安非他酮。我们的主要终点 评估是通过生化验证的自我报告戒烟率 三个治疗组之间不同时间点的验证。