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旨在帮助人们实现永久戒烟的两种治疗策略激活的疗效和变化机制。关于药物动机和学习的基础研究表明，改变环境事件、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1，复发仍然是任何戒烟后最有可能的结果2。虽然治疗的进步已经帮助许多人戒烟，但更多的人希望戒烟，但尽管一再尝试，却未能成功。拟议的项目将使用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与其前因和后果之间的独特学习联系。第一种策略涉及通过七个逐渐延长的戒烟期或“练习戒烟”阶段来分级暴露于厌恶性尼古丁戒断症状，然后进行厌恶性吸烟程序，以减少每次练习戒烟后重新吸烟的强化作用。第二种策略涉及在戒烟尝试的前6周内吸脱尼古丁香烟，以便通过关联效应暂时减少戒断，然后消除尼古丁自我给药仪式。拟定研究包括3种处理条件。所有受试者将接受标准戒烟治疗（ST），包括6周疗程的经皮尼古丁贴片治疗和个体戒烟咨询。对照条件将仅接受此处理。标准治疗加戒断暴露+吸烟控制（ST+WE/SH）条件下的受试者也将接受分级的戒断暴露和戒烟前吸烟控制。处于最终状态（ST+WE/SH+DC）的受试者将接受标准治疗、戒断暴露和戒烟，并在停止使用常用品牌香烟后接受6周脱尼古丁香烟供应。我们预测，ST+WE/SH将促进禁欲，相对于ST条件，ST+WE/SH+DC将促进禁欲相对于ST+WE/SH。我们预测ST+WE/SH将主要消除吸烟与其前因之间的习得性联系（例如，而ST+WE/SH+DC将在戒烟尝试的早期提供条件性戒断缓解，并最终消除吸烟与其积极后果之间的关联。我们将使用中介分析来研究这些假设。这项研究的目的是确定新的，基于学习的治疗成分，可以添加到现有的治疗，以增加成功戒烟。 公共卫生相关性：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，结合不同的治疗是否会提高戒烟率，并将确定可能导致治疗益处的变化。该项目将测试行为和药物治疗的有效性，这些治疗旨在中断吸烟触发因素、吸烟行为和吸烟的积极后果之间的习得性关联。

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.