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Varenicline and Smoking Cessation in Schizophrenia

伐尼克兰与精神分裂症的戒烟

基本信息

批准号：
7894863
负责人：
seyyed HOSSEIN FATEMI
金额：
$ 42.44万
依托单位：
UNIVERSITY OF MINNESOTA
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-08-01 至 2012-07-31
项目状态：
已结题

项目摘要

DESCRIPTION (provided by applicant): Schizophrenia is a major debilitating brain disorder that affects 1% of the world's population. There is a 90% prevalence rate of comorbid nicotine addiction in schizophrenic patients leading to high morbidity and mortality rate in this vulnerable population. The smoking cessation agent bupropion HCl has been tested in schizophrenics, but the results on its efficacy are inconclusive. Recent works by different laboratories have shown the safety and efficacy of varenicline, a partial 1422 and full 17 nicotinic acetylcholine receptor agonist, as a smoking cessation agent. However, to date, no published studies have tested the safety and efficacy of varenicline in treatment of nicotine dependence in schizophrenic patients. As varenicline appears to be a promising treatment in non-psychiatric patients, it would be beneficial to examine its effects in schizophrenic patients. The central hypothesis of this application is that treatment with varenicline will safely increase smoking abstinence rates in schizophrenic patients when compared to those receiving placebo. This central hypothesis will be tested and the objectives of this application accomplished by pursuing two Specific Aims: 1) Treatment with varenicline or bupropion HCl for a period of three months will increase smoking abstinence rates in schizophrenic patents when compared to placebo; and 2) Treatment with varenicline or bupropion HCl for a period of three months will not increase psychosis in schizophrenic patients when compared to placebo. We will employ a double-blind randomized placebo controlled study to assess varenicline's safety and efficacy. It is our expectation that we will demonstrate that varenicline is safe and effective in decreasing smoking rates in schizophrenic patients without exacerbating psychotic symptoms. Such outcomes will be significant, because they will offer a new treatment for smoking cessation in this vulnerable population. PUBLIC HEALTH RELEVANCE: Schizophrenia is a major debilitating brain disorder that affects 1% of the world's population with a 90% prevalence rate of comorbid nicotine addiction in schizophrenic patients, leading to high morbidity and mortality rate in this vulnerable population. As varenicline appears to be a promising treatment in non-psychiatric patients, it would be beneficial to examine its effects in schizophrenic patients. The central hypothesis of this application is that treatment with varenicline will safely increase smoking abstinence rates in schizophrenic patients when compared to those receiving placebo. It is our expectation that we will demonstrate that varenicline is safe and effective in decreasing smoking rates in schizophrenic patients without exacerbating psychotic symptoms. Such outcomes will be significant, because they will offer a new treatment for smoking cessation in this vulnerable population.

描述(申请人提供)：精神分裂症是一种严重的脑部疾病，影响世界1%的人口。精神分裂症患者中有90%的尼古丁成瘾共病，这导致了这一弱势群体的高发病率和死亡率。戒烟剂盐酸安非他酮已经在精神分裂症患者中进行了测试，但其疗效尚不确定。不同实验室最近的研究表明，部分1422和完整17烟碱型乙酰胆碱受体激动剂varenicline作为戒烟剂的安全性和有效性。然而，到目前为止，还没有发表的研究测试伐伦克林治疗精神分裂症患者尼古丁依赖的安全性和有效性。由于varenicline似乎是一种对非精神病患者有希望的治疗方法，因此检查其在精神分裂症患者中的效果将是有益的。这一应用的中心假设是，与接受安慰剂治疗的患者相比，使用varenicline治疗将安全地增加精神分裂症患者的戒烟率。这一核心假设将得到检验，本申请的目标将通过追求两个具体目标来实现：1)与安慰剂相比，用varenicline或安非他酮盐酸盐治疗3个月将增加精神分裂症患者的戒烟率；2)与安慰剂相比，用varenicline或安非他酮盐酸盐治疗3个月不会增加精神分裂症患者的精神错乱。我们将采用双盲随机安慰剂对照研究来评估伐伦克林的安全性和有效性。我们的期望是，我们将证明varenicline在降低精神分裂症患者吸烟率方面是安全和有效的，而不会加剧精神症状。这样的结果将是重要的，因为它们将为这一脆弱人群的戒烟提供一种新的治疗方法。公共卫生相关性：精神分裂症是一种主要的使人衰弱的大脑疾病，影响着世界1%的人口，精神分裂症患者中90%的人患有尼古丁成瘾，导致这一脆弱人群的高发病率和死亡率。由于varenicline似乎是一种对非精神病患者有希望的治疗方法，因此检查其在精神分裂症患者中的效果将是有益的。这一应用的中心假设是，与接受安慰剂治疗的患者相比，使用varenicline治疗将安全地增加精神分裂症患者的戒烟率。我们的期望是，我们将证明varenicline在降低精神分裂症患者吸烟率方面是安全和有效的，而不会加剧精神症状。这样的结果将是重要的，因为它们将为这一脆弱人群的戒烟提供一种新的治疗方法。