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.

说明（由申请人提供）：吸烟会对健康造成严重但可预防的危害。尽管吸烟的有害影响是