Combination Nicotine Replacement for Alcoholic Smokers

描述（由申请人提供）：这是一项名为“酒精治疗中戒烟的实地研究”的补助金的竞争性更新。酗酒者吸烟是一个重大的公共卫生问题。本研究的广泛目标是在门诊酒精中毒治疗的初始阶段为酒精吸烟者提供经验支持的戒烟治疗建议。在一项双盲安慰剂对照临床试验中；将从社区招募175名酒精依赖吸烟者，并在6个月的门诊酒精和烟草治疗方案中接受治疗。所有受试者将接受15次单独治疗，目标是戒除烟酒。他们还将随机接受两种尼古丁替代疗法（NRT）中的一种。一组接受由活性尼古丁贴片和活性尼古丁口香糖组成的联合尼古丁尼古丁疗法，而对照组接受由活性尼古丁贴片和安慰剂尼古丁口香糖组成的单一尼古丁尼古丁疗法。吸烟和饮酒的结果将在治疗开始的一年内进行评估。除了结果评估外，生态瞬时评估（EMA）方法将用于检查治疗过程。EMA数据将使用结合交互式语音应答技术的移动电话收集，随机抽样每个受试者在戒烟前两周、戒烟后两周和戒烟后两个月在自然环境中的体验。这一方法将被用于(a)比较单一和联合NRT对吸烟和饮酒冲动的频率和强度的总体影响；(b)确定自我服用尼古丁GWN对随后短暂的饮酒冲动和吸烟冲动的直接影响；(e)确定饮酒和吸烟的冲动对随后自我服用尼古丁口香糖的短暂影响。这些过程分析的结果将有助于更好地了解尼古丁替代对酗酒吸烟者的影响以及影响他们对尼古丁口香糖依从性的因素。

DESCRIPTION (provided by applicant): This is a competitive renewal of a grant entitled "Field Study of Smoking Cessation in Alcohol Treatment." Tobacco use among alcoholics is a major public health problem. The broad objective of this study is to develop recommendations for empirically supported smoking cessation treatment for alcoholic smokers in the initial phase of outpatient alcoholism treatment. In a double blind, placebo controlled clinical trial; a sample of 175 alcohol dependent cigarette smokers will be recruited from the community and treated in a six month outpatient alcohol and tobacco treatment protocol. All subjects will be offered a total of 15 individual treatment sessions with a goal of abstinence from alcohol and tobacco. They will also be randomized to one of two levels of nicotine replacement therapy (NRT). One group will receive Combination INRT consisting of active nicotine patch and active nicotine gum, while a comparison group will receive Single NRT consisting of active nicotine patch and placebo nicotine gum. Smoking and drinking outcome will be assessed across one year from the onset of treatment. In addition to the outcome assessment, Ecological Momentary Assessment (EMA) methodology will be used to examine treatment process. EMA data will be collected using cellular telephones combined with Interactive Voice Response technology to randomly sample each subject's experience in the natural environment during two week periods before smoking cessation, immediately after smoking cessation, and two months after smoking cessation. This methodology will be used (a) to compare the overall effects of Single versus Combination NRT on frequency and intensity of urge to smoke and urge to drink; (b) to determine the immediate impact of nicotine gwn self administration on subsequent momentary urge to drink and urge to smoke; and (e) to determine the momentary effect of urges to drink and urges to smoke on subsequent nicotine gum self administration. The results of these process analyses will lead to improved understanding of the effects of nicotine replacement on alcoholic smokers and factors affecting their compliance with nicotine gum.