Bupropion as a Smoking Cessation Aid in Alcoholics

安非他酮作为酗酒者的戒烟辅助剂

• 批准号: 6629408
• 负责人: Kathleen Mary Grant
• 金额: $ 7.5万
• 依托单位: OMAHA VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-05-01 至 2005-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6629408
• 关键词: adult human (21+); alcoholic beverage consumption; alcoholism /alcohol abuse; alcoholism /alcohol abuse therapy; antidepressants; behavioral /social science research tag; bupropion; clinical trials; comorbidity; drug adverse effect; human subject; human therapy evaluation; longitudinal human study; mental disorder chemotherapy; nicotine replacement; patient oriented research; pharmacology; slow release drug; smoking; smoking cessation; therapy compliance; tobacco abuse

DESCRIPTION (provided by applicant): Objectives: The purpose of the current proposal is to test the use of sustained release bupropion in patients in treatment for alcohol abuse/dependence as an aid for smoking cessation. It is our overall hypothesis that cigarette smoking cessation can be achieved in patients during treatment for alcohol abuse/addiction, particularly if treatment is tailored. Our proposed work will address the following four specific aims: Aim one will assess whether the use of sustained release bupropion as a smoking cessation alters abstinence from cigarette smoking for patients with alcohol abuse/dependence in an alcohol treatment program. Aim two will assess whether the use of sustained release bupropion as a smoking cessation aid alters sobriety from alcohol in patients. Aim three will assess the incidence of side effects of sustained release bupropion when used as a smoking cessation aid for patients with alcohol abuse or dependence in an alcohol treatment program. Aim four will assess the adherence to the medication regimen between the two groups. Research Design and Methodology: We propose to use a randomized, double blind, placebo controlled clinical trial to test the safety and efficacy of the addition of a nine-week course of sustained release bupropion for cigarette smoking cessation in a VA SATC and a community-based alcohol treatment program. 200 total patients will be enrolled. Patients meeting study criteria will be randomized to receive either sustained released bupropion or placebo. Both groups will receive nicotine replacement therapy. Participants will be followed for 6 months. A repeated measure design will be used to compare outcome measures of smoking cessation and sobriety from alcohol in two groups (control, intervention) at baseline, 4 weeks, 9 weeks, and 6 months.

描述（申请人提供）：目标：当前的目的 提案是测试患者中持续释放安非他酮的使用 治疗酒精滥用/依赖性作为戒烟的帮助。这是 我们的总体假设可以在 酗酒/成瘾治疗期间的患者，特别是 治疗是量身定制的。我们建议的工作将解决以下四个 具体目的：目标一个人将评估是否使用持续释放 安非他酮作为吸烟戒烟会改变吸烟的戒酒 酒精治疗计划中酗酒/依赖的患者。目的 两个将评估是否使用持续释放安非他酮作为吸烟 戒烟有助于改变患者酒精的清醒。目标三将评估 当用作持续释放安非他酮的副作用的发生率 戒烟援助酗酒或依赖的患者 酒精治疗计划。目标四将评估遵守 两组之间的药物治疗方案。 研究设计和方法论：我们建议使用随机，双盲， 安慰剂对照临床试验，以测试 增加九周的持续释放安非他酮的课程 在VA SATC和社区酒精治疗中戒烟 程序。总共有200名患者。患者开展研究 标准将随机接收持续释放的安非他酮或 安慰剂。两组将接受尼古丁替代疗法。参与者 将遵循6个月。重复的措施设计将用于 比较两者中戒烟和清醒的结果度量 基线，4周，9周和6个月的组（对照，干预）。