Combination Nicotine Replacement for Alcoholic Smokers

描述（由申请人提供）：这是一个题为“酒精治疗中戒烟的实地研究”的资助的竞争性更新。“酗酒者吸烟是一个重大的公共卫生问题。本研究的主要目的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名酒精依赖性吸烟者的样本，并在6个月的门诊酒精和烟草治疗方案中进行治疗。所有受试者将接受总计15次个体治疗，目标是戒酒和戒烟。他们还将被随机分配到两个尼古丁替代疗法（NRT）水平之一。一组将接受由活性尼古丁贴片和活性尼古丁咀嚼胶组成的联合INRT，而对照组将接受由活性尼古丁贴片和安慰剂尼古丁咀嚼胶组成的单一NRT。吸烟和饮酒的结果将在治疗开始后一年内进行评估。除了结果评估外，生态瞬时评估（EMA）方法将用于检查处理过程。EMA数据将使用移动电话结合交互式语音应答技术收集，以随机抽样每例受试者在戒烟前两周、戒烟后即刻和戒烟后两个月内在自然环境中的经历。该方法将用于（a）比较单药与复方NRT对吸烟欲望和饮酒欲望频率和强度的总体影响;（B）确定尼古丁自我给药对后续瞬时饮酒欲望和吸烟欲望的即时影响;以及（e）确定饮酒欲望和吸烟欲望对后续尼古丁咀嚼胶自我给药的瞬时影响。这些过程分析的结果将有助于更好地了解尼古丁替代对酒精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.