Distress Tolerance Treatment for Early Smoking Lapsers

描述（由申请人提供）： 尝试戒烟的人中有很大一部分在几天内就开始吸烟，很少有人能够恢复到戒烟的状态。目前的复发模型对这种早期复发现象关注不够。试图将尼古丁戒断症状的严重程度与短期戒烟结果联系起来的研究产生了模棱两可的结果。我们相信，人们对尼古丁戒断和戒烟的不适反应是一个更有希望的调查途径，可能具有重要的治疗意义。早期吸烟者（即，从未戒烟超过72小时的吸烟者代表了一个特殊的高风险群体，他们将受益于专门的戒烟治疗，以满足他们的独特需求。在本申请中，我们提出开发并获得关于早期失败者的痛苦耐受治疗（DT）的功效的初步数据。在该项目的第一阶段（阶段Ia），我们将为早期吸烟者制定一项专门的治疗方案，该方案利用尼古丁戒断的行为暴露和基于接受和承诺疗法（ACT）的技能培训，以促进对戒烟相关痛苦的耐受。在此阶段，20名早期吸烟者将完成该方案，该方案将根据参与者和临床医生的反馈进行修改和完善。在第二阶段（阶段Ib），我们将进行初步的随机临床试验，检查DT治疗与标准戒烟治疗（ST）相比的功效。所有受试者将接受8周的尼古丁透皮贴剂。参与者将被跟踪6个月，自我报告的禁欲将通过一氧化碳和唾液可替宁进行验证。我们还将研究的假设，任务的持久性和情绪回避的变化之前，退出日期将调解DT治疗的效果。我们希望这项研究将导致开发一种针对早期吸烟者的明确和新颖的行为痛苦耐受治疗方法，然后将为大规模临床试验做好准备。从长远的角度来看，我们预计这项研究计划将导致开发一种专门的，有效的治疗早期吸烟者，一个重要的亚群吸烟者在戒烟困难的风险最大，因此将有重要的临床和公共卫生意义，在降低吸烟的总体流行率。

DESCRIPTION (provided by applicant): A significant percentage of individuals attempting smoking cessation lapse to smoking within a matter of days, and very few are able to recover to achieve abstinence from smoking. Current models of relapse devote insufficient attention to this phenomenon of early lapse. Studies attempting to relate severity of nicotine withdrawal symptoms to short-term smoking cessation outcomes have yielded equivocal results. We believe that how one reacts to the discomfort of nicotine withdrawal and quitting smoking is a more promising avenue of investigation and may have important treatment implications. Early smoking lapsers (i.e., smokers who have never been able quit smoking for more than 72 hours) represent a particular high-risk group who would benefit from specialized smoking cessation treatment to address their unique needs. In the present application, we propose to develop and obtain preliminary data on the efficacy of a distress tolerance treatment (DT) for early lapsers. In the first phase of this project (Stage Ia), we will develop a specialized treatment protocol for early smoking lapsers that utilizes behavioral exposure to nicotine withdrawal and training in skills based in Acceptance and Commitment Therapy (ACT) to facilitate tolerance of distress associated with quitting smoking. During this phase, 20 early smoking lapsers will complete the protocol, which will be modified and refined based upon feedback from participants and clinicians. In the second phase (Stage lb), we will conduct a preliminary, randomized clinical trial, examining its efficacy of the DT treatment in comparison to standard smoking cessation treatment (ST). All subjects will receive 8 weeks of transdermal nicotine patch. Participants will be followed over 6 months, and self-reported abstinence will be verified by carbon monoxide and saliva cotinine. We will also examine the hypothesis that changes in task persistence and emotional avoidance prior to quit date will mediate the effect of DT treatment. We expect that this study will result in the development of a well-specified and novel behavioral distress tolerance treatment for early smoking lapsers that will then be readied for a large-scale clinical trial. From a longer term perspective, we expect that this program of research will result in the development of a specialized, efficacious treatment for early smoking lapsers, a significant subpopulation of smokers at greatest risk for difficulties quitting, and will therefore have important clinical and public health significance in decreasing the overall prevalence of cigarette smoking.