Duration of Behavioral Counseling Treatment Needed to Optimize Smoking Abstinence

描述（由申请人提供）： 尼古丁依赖越来越被认为是一种复杂的慢性疾病。只有10-20%接受戒烟干预的吸烟者能够保持戒烟1年。戒烟计划的不良结果可能是由于大多数现有的补充药物治疗的行为治疗的短暂和有限的强度。在我们的实验室中，我们发现吸烟者接受密集的、高剂量的个体化尼古丁贴片治疗，同时只接受非常少的行为咨询，戒烟率非常低（14%）。我们提出一项研究，将检查，使用随机，仔细对照的实验设计，是否使用持续时间较长的咨询协议的中等强度将显着提高戒烟率。我们的研究将提供我们所知的第一个信息，即在接受尼古丁替代治疗的患者中，最大限度地提高戒烟率所需的最佳咨询持续时间。我们将招募450名吸烟者，并提供尼古丁贴片治疗12周。受试者将被随机分配至以下戒烟后咨询条件之一：（A）12周，（B）24周，或（C）52周咨询。我们的研究将提供Hall等人最近开创性工作的复制和显著扩展（Hall等人，Am J Psychiatry 2004;161：2100-2107），其在小样本中发现，52周持续时间的延长咨询方案产生50- 55%的1年戒烟率。我们将确定是否使用延长时间的咨询协议可以获得类似的戒烟率在1年后戒烟的一个大的，更严重的依赖吸烟者的代表性样本。我们还将确定是否需要52周的治疗方案来产生最佳的戒烟率，或者是否需要更短的治疗时间（6个月），也许更容易被吸烟者接受，可能同样有效，或者几乎同样有效。此外，我们将研究机制（例如，社会支持），通过延长持续时间的咨询可能会增加戒烟率，并跟踪吸烟者2年，以评估在随机分配到更长持续时间的咨询条件下的第1年假设较高戒烟率的持久性。第二个目标将检查是否延长咨询时间可能是特别有益的某些亚组，如妇女，教育程度较低，和那些有抑郁症状。我们还将提供关于吸烟者在戒烟尝试的不同戒烟后阶段所经历的困难的信息，这可能对未来特定时间的治疗干预措施的发展有用。如果我们关于延长咨询时间的有效性的主要假设得到支持，这将表明一种新的治疗模式，包括更频繁和结构化的接触，更长的观察期，以及在复发时重新尝试戒烟，可能是必要的，以减少美国吸烟者中越来越多的吸烟者的吸烟率。 大多数尝试戒烟的吸烟者（约80-95%）都会出现复发（重新吸烟）。我们的研究将测试使用延长时间的咨询程序对改善重度依赖吸烟者长期戒烟结果的有效性。这一系列研究的最终目标是开发治疗方法，增加吸烟者成功戒烟的可能性。

DESCRIPTION (provided by applicant): Nicotine dependence is increasingly recognized as a complex and chronic condition. Only 10-20% of smokers receiving smoking-cessation interventions are able to maintain abstinence for 1 year. Poor outcomes from smoking-cessation programs may be due to the brevity and limited intensity of most existing behavioral treatments that supplement pharmacologic treatment. In our laboratory we have found very low quit rates (14%) for smokers given intensive, high-dose individualized nicotine patch therapy accompanied by only very minimal behavioral counseling. We are proposing a study that will examine, using a randomized, carefully-controlled experimental design, whether use of extended-duration counseling protocols of moderate intensity will significantly improve cessation rates. Our study will provide the first information to our knowledge regarding the optimal duration of counseling needed to maximize cessation rates among those receiving nicotine replacement treatment. We will recruit a sample of 450 smokers and provide nicotine patch treatment for 12 weeks. Subjects will be randomly assigned to one of the following post-quit counseling conditions: (A) 12 weeks, (B) 24 weeks, or (C) 52 weeks of counseling. Our study will provide a replication and significant extension of the recent seminal work of Hall et al. (Hall et al., Am J Psychiatry 2004;161:2100-2107) that found, in a small sample, that an extended counseling protocol of 52 weeks duration produced 1-year quit rates of 50-55%. We will determine whether use of extended-duration counseling protocols can obtain similar quit rates at 1 year post-cessation among a large, representative sample of more heavily-dependent smokers. We will also determine whether a 52-week treatment protocol is necessary to produce optimal cessation rates, or whether a shorter-duration treatment (6 months), perhaps more acceptable to smokers, might be as effective, or nearly as effective. In addition, we will examine mechanisms (e.g., social support) through which extended duration counseling may increase cessation rates, and follow smokers for 2 years to assess the durability of the assumed higher quit rates at year 1 among those randomized to the more extended duration counseling conditions. Secondary aims will examine whether extended duration counseling may be especially beneficial for certain subgroups such as women, those of lower education, and those with depressive symptoms. We will also provide information on the difficulties that smokers experience at different post-cessation periods of the quit attempt which may be useful for the development of future time-specific treatment interventions. If our prime hypothesis concerning the efficacy of extended-duration counseling is supported, this would suggest that a new treatment model, involving more frequent and structured contact, longer periods of observation, and renewed quit attempts in the event of relapse, may be necessary to reduce the prevalence of cigarette smoking among the increasingly recalcitrant population of smokers in the United States. Project Narrative Relapse (return to smoking) occurs for the majority of smokers (approximately 80-95%) who try to quit. Our study will test the efficacy of using an extended-duration counseling procedure for improving long-term cessation outcomes among more heavily-dependent smokers. The ultimate goal of this line of research is to develop treatments that will increase the likelihood that smokers will succeed in their quit attempts.