Evaluation of Learning-Theory-Based Smoking Cessation Strategies

描述(由申请人提供)：拟议的临床试验将评估两种旨在帮助人们实现永久戒烟的治疗策略的有效性和变化机制。关于药物动机和学习的基础研究表明，改变背景事件、药物使用和戒烟尝试前使用的强化后果之间的关联可能会提高戒烟的成功率。吸烟仍然是美国成年人死亡的主要可预防原因，复发仍然是任何戒烟尝试最有可能的结果2。虽然治疗的进步帮助了许多人戒烟，但更多的人希望戒烟，但尽管多次尝试，但还是失败了。拟议的项目将使用一项实验设计来评估两种治疗策略的有效性，这两种治疗策略旨在改变吸烟及其前因和后果之间的不同习得联系。第一种策略包括通过七个逐渐延长的戒烟期或“练习戒烟”过程来分级暴露于令人厌恶的尼古丁戒断症状，然后进行厌恶的控烟程序，以减少每次练习戒烟后重新吸烟的强化效果。第二种策略包括在戒烟尝试的前6周内抽去尼古丁香烟，以通过联想效应暂时减少戒烟，然后熄灭尼古丁自我管理程序。建议的研究包括3个治疗条件。所有受试者都将接受标准的戒烟治疗(ST)，包括为期6周的经皮尼古丁贴片治疗和个人戒烟咨询。控制条件将只接受这种治疗。在标准治疗加戒断暴露控烟(ST WE/SH)条件下，受试者也将接受分级戒断暴露和戒烟前的戒烟。在最后一种情况下(ST WE/SH DC)的受试者将接受标准治疗、戒断暴露和禁烟，并在戒除普通品牌香烟后提供6周的去烟味香烟供吸烟。我们预测，相对于ST状态，ST WE/SH将促进戒断，而相对于ST WE/SH，ST WE/SH DC将促进戒断。我们预测，ST WE/SH将主要消除吸烟及其前因(例如戒断痛苦)之间的习得联系，而ST WE/SH DC将在戒烟尝试的早期阶段提供有条件的戒断缓解，并最终消除吸烟与其积极后果之间的联系。我们将使用中介分析来研究这些假设。这项研究的目标是确定新的、基于学习的治疗成分，这些成分可以添加到现有的治疗方法中，以增加成功的戒烟。 与公共健康相关：这项拟议的研究将测试两种旨在帮助吸烟者戒烟的治疗策略。这项研究将告诉我们，结合不同的治疗方法是否会提高戒烟率，并将确定可能解释治疗益处的变化。该项目将测试行为和药物治疗的有效性，旨在中断吸烟诱因、吸烟行为和吸烟的积极后果之间的已知联系。

DESCRIPTION (provided by applicant): The proposed clinical trial will assess the efficacy of and mechanisms of change activated by two treatment strategies designed to help people achieve permanent abstinence from tobacco. Basic research on drug motivation and learning suggests that altering associations among setting events, drug use, and the reinforcing consequences of use prior to a smoking cessation attempt may enhance success in quitting. Smoking remains the leading preventable cause of death among adults in the U.S.1 and relapse remains the most likely outcome of any smoking cessation attempt2. Although treatment advances have helped many people quit smoking, many more wish to quit but fail to do so despite repeated attempts2. The proposed project will use an experimental design to assess the efficacies of two treatment strategies designed to alter distinct learned associations between smoking and its antecedents and consequences. The first strategy involves graded exposure to aversive nicotine withdrawal symptoms through seven progressively longer periods of abstinence, or "practice quitting" sessions, followed by an aversive smoke holding procedure that will reduce the reinforcing effects of returning to smoking after each practice quitting session. The second strategy involves smoking denicotinized cigarettes for the first 6 weeks of a quit attempt in order to temporarily reduce withdrawal through associative effects and then extinguish the nicotine self-administration ritual. The proposed study comprises 3 treatment conditions. All subjects will receive a standard cessation treatment (ST) including a 6-weeks course transdermal nicotine patch therapy and individual smoking cessation counseling. The control condition will receive only this treatment. Subjects in the standard treatment plus Withdrawal Exposure + Smoke Holding (ST+WE/SH) condition will also receive graded withdrawal exposure and smoke holding pre-quit. Subjects in the final condition (ST+WE/SH+DC) will receive standard treatment, withdrawal exposure and smoke holding, and a 6-week supply of denicotinized cigarettes to smoke after quitting use of usual-brand cigarettes. We predict that ST+WE/SH will promote abstinence, relative to the ST condition, and that ST+WE/SH+DC will promote abstinence relative to ST+WE/SH. We predict that ST+WE/SH will primarily extinguish learned associations between smoking and its antecedents (e.g., withdrawal distress) whereas ST+WE/SH+DC will provided conditioned withdrawal relief in the early part of the quit attempt and will ultimately extinguish associations between smoking and its positive consequences. We will investigate these hypotheses using mediation analyses. The goal of this research is to identify new, learning-based treatment components that can be added to existing treatments to increase successful smoking cessation. PUBLIC HEALTH RELEVANCE: The proposed study will test two treatment strategies designed to help smokers quit smoking. The study will tell us whether combining distinct treatments enhances quitting rates and will identify changes that may account for treatment benefits. The project will test the efficacy of behavioral and pharmacological treatments designed to interrupt learned associations among triggers to smoke, smoking behavior, and the positive consequences of smoking.