1/2-Multi-site Study: Varenicline Treatment of Alcohol Dependent Smokers

1/2 多中心研究：伐尼克兰治疗酒精依赖型吸烟者

• 批准号: 8617200
• 负责人: STEPHANIE S O'MALLEY
• 金额: $ 56.83万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-03-05 至 2016-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8617200
• 关键词: Abstinence; Address; Aftercare; Alcohol consumption; Alcohol dependence; Alcoholic beverage heavy drinker; Alcoholism; Alcohols; Attenuated; Behavior Therapy; Biochemical; Biological; Biological Assay; Cigarette; Cigarette Smoker; Clinical Trials; Cotinine; Counseling; Cues; Data; Dopamine; Double-Blind Method; Eligibility Determination; Ethanol; Evaluation; FDA approved; Genetic; Glucuronides; Goals; Heavy Drinking; Human; Individual; Industry; Intervention; Laboratories; Maintenance; Measures; Mediator of activation protein; Monitor; Morbidity - disease rate; National Institute on Alcohol Abuse and Alcoholism; Nicotine; Nicotine Dependence; Nicotinic Receptors; Participant; Patient Self-Report; Pharmacotherapy; Pharmacy facility; Phase; Placebo Control; Placebos; Population; Pre-Clinical Model; Quality Control; Randomized; Recruitment Activity; Refractory; Reporting; Research; Resources; Safety; Sample Size; Site; Site Visit; Smoker; Smoking; Teleconferences; Testing; Tobacco; Training; Treatment outcome; United States National Institutes of Health; Urine; Work; acetylcholine receptor agonist; alcohol abuse therapy; alcohol craving; alcoholism therapy; base; cigarette smoking; clinical care; craving; data management; drinking; efficacy testing; experience; follow-up; meetings; mortality; non-smoker; placebo controlled study; pre-clinical research; receptor; response; secondary outcome; smoking cessation; therapeutic target; treatment duration; varenicline; web site

DESCRIPTION (provided by applicant): The objective of this proposed Columbia-Yale collaborative project is to test the efficacy of varenicline for the treatment of alcohol dependenc among individuals who also report daily cigarette smoking. Alcohol dependent smokers have poorer alcoholism treatment outcomes and experience greater morbidity and mortality than alcohol dependent nonsmokers. The strong association between smoking and alcohol dependence suggests that common underlying factors may provide a therapeutic target for alcohol and nicotine use. Nicotinic acetylcholine receptors are the primary target of nicotine, and these receptors are involved in alcohol dependence. Varenicline is a partial nicotinic acetylcholine receptor antagonist with documented efficacy for smoking cessation. Varenicline also shows promise as a potential treatment for alcohol dependence based on preclinical models and recent human preliminary studies in heavy drinking smokers. Research conducted at Yale found that varenicline substantially reduces alcohol craving and drinking (compared to placebo) in a laboratory-alcohol administration paradigm and in a 3-week placebo controlled preliminary study. Based on these promising findings, the proposed study is a collaborative RO1 Phase II randomized double-blind placebo controlled 16-week study of varenicline for the treatment of alcohol drinking among 160 alcohol dependent daily smokers recruited at Yale and Columbia. The primary hypothesis is that varenicline will significantly reduce the percentage of heavy drinking days during the last two months of the treatment period. A secondary aim is to test the hypothesis that varenicline will promote smoking abstinence among alcohol dependent individuals who are not seeking smoking cessation counseling. Other secondary aims are to evaluate the effects of varenicline on alcohol and tobacco craving and the maintenance of change up through one-year. Finally, exploratory analyses will be conducted of moderators and mediators of varenicline effects. The combined recruitment resources and expertise of Yale and Columbia will advance the goals of the project. The potential benefits of varenicline, if confirmed, would represent a significant advance for the treatment of alcohol dependent smokers.

描述（由申请人提供）：该拟议的哥伦比亚还可以合作项目的目的是测试Varenicline在还报告每天吸烟的个体中对酒精依赖治疗的疗效。与酒精依赖的非吸烟者相比，依赖酒精的吸烟者的酒精中毒治疗结果较差，发病率和死亡率更高。吸烟与酒精依赖之间的密切关联表明，常见的潜在因素可以为酒精和尼古丁使用提供治疗靶标。烟碱乙酰胆碱受体是尼古丁的主要靶标，而 这些受体参与酒精依赖。 Varenicline是一种部分烟碱乙酰胆碱受体拮抗剂，具有记录在戒烟的效力中。 Varenicline还显示了基于临床前模型和最近在大量饮酒者中的人类初步研究的酒精依赖的潜在治疗方法。在耶鲁大学进行的研究发现，在实验室 - 酒精给药范式和3周安慰剂控制的初步研究中，Varenicline大大降低了酒精的渴望和饮酒（与安慰剂相比）。基于这些有希望的发现，拟议的研究是一项合作的RO1 II期随机性双盲安慰剂控制的16周研究研究，用于治疗耶鲁大学和哥伦比亚招募的160名酒精依赖的每日吸烟者中饮酒。主要的假设是，在治疗期的最后两个月中，Varenicline将显着降低大量饮酒日的百分比。第二个目的是检验以下假设：Varenicline将促进不寻求戒烟咨询的依赖酒精的人的戒烟。其他次要目的是评估Varenicline对酒精和烟草渴望的影响，并在一年中维持变化。最后，将对Varenicline效应的主持人和介体进行探索性分析。耶鲁大学和哥伦比亚的综合招聘资源和专业知识将促进该项目的目标。如果确认，Varenicline的潜在益处将代表治疗依赖酒精的吸烟者的重大进步。