Withdrawal Exposure with Withdrawal Regulation Training for Smoking Cessation

描述（由申请人提供）：在美国，吸烟仍然是导致死亡和发病的最可预防的单一原因。即使是最严格的戒烟治疗，长期戒断率也在20%到35%之间。因此，有必要继续研究新的戒烟干预措施。大量证据表明，戒断过程构成了吸烟的动机基础，并在再次吸烟中起着关键作用。虽然戒除尼古丁或药物戒除可能限于10天，但戒除吸烟行为或行为戒除可能无限期持续。因此，有人建议，戒烟干预措施可以通过帮助吸烟者在戒断调节策略的实践中得到加强。本研究的主要目的是试点体内早期戒断暴露与戒断调节训练干预戒烟。具体目标包括：告知调查实验干预的可行性；确定实验性治疗的潜在疗效；调查实验治疗的中介和调节者。参与者将是成年吸烟者（N = 50），每天至少吸烟10支，并有意戒烟。他们将被随机分配到两种条件中的一种：早期戒断暴露+戒断调节训练（E + WT）或放松训练控制（RT）。E + WT条件将包括个体化戒断调节策略（例如，减轻戒断症状的行为和认知策略）的发展、应用、修改和重复实践，在三个独立的会话中，每个会话将跨越戒断的前四个小时。RT条件将控制那些在E + WT条件下接受治疗接触的人。虽然拟议的调查有望被证明是可行的，但拟议的试点研究将提供一系列对研究设计、招募和保留策略以及治疗方案（包括治疗手册）的推进至关重要的数据。此外，结果数据将允许改进实验干预的效应大小估计。最后，候选介质（如戒断症状）和调节因子（如烟草依赖）将通过既定的分析进行调查。这些数据将推动实验性干预，重点关注改变的目标机制以及干预可能量身定制的参与者特征。当前应用中描述的实验性干预有可能最终提高现有戒烟干预措施的功效，因此将对该领域做出独特的贡献。

DESCRIPTION (provided by applicant): Cigarette smoking remains the single most preventable cause of mortality and morbidity in the United States. Long-term abstinence rates for even the most rigorous of smoking cessation treatments range between 20 percent and 35 percent. It is therefore essential that research continue to investigate novel smoking cessation interventions. Considerable evidence suggests that withdrawal processes form the motivational basis for cigarette smoking and play a critical role in relapse to cigarette use. While withdrawal from nicotine, or pharmacologic withdrawal, may be limited to 10 days, withdrawal from the act of smoking, or behavioral withdrawal, may persist indefinitely. Accordingly, it has been suggested that smoking cessation interventions may be augmented by aiding smokers in the practice of withdrawal regulation strategies. The primary goal of this investigation is to pilot an in vivo early withdrawal exposure with withdrawal regulation training intervention for smoking cessation. Specific aims include: informing the feasibility of investigating the experimental intervention; determining the experimental treatment's potential efficacy; and investigating mediators and moderators of the experimental treatment. Participants will be adult smokers (N = 50) of at least 10 cigarettes per day with the intention to quit smoking. They will be randomized to one of two conditions: Early Withdrawal Exposure + Withdrawal Regulation Training (E + WT) or Relaxation Training control (RT). The E + WT condition will consist of the development, application, modification, and repeated practice of individualized withdrawal regulation strategies (e.g., behavioral and cognitive strategies for allaying withdrawal symptoms) over three separate sessions that will each span the first four hours of abstinence. The RT condition will control for the therapeutic contact received by those in the E + WT condition. While the proposed investigation is expected to prove feasible, the proposed pilot study will provide an array of data critical to the advancement of the study design, recruitment and retention strategies, and treatment protocol, which includes the treatment manuals. Furthermore, outcome data will allow for the refinement of effect size estimates of the experimental intervention. Finally, candidate mediators (e.g., withdrawal symptoms) and moderators (e.g., tobacco dependence) will be investigated via established analyses. These data will advance the experimental intervention with a focus on targeting mechanisms of change as well as participant characteristics to which the intervention may be tailored. The experimental intervention described in the current application has the potential to ultimately enhance the efficacy of existing smoking cessation interventions and will therefore contribute uniquely to the field.