Duration of Behavioral Counseling Treatment Needed to Optimize Smoking Abstinence

描述(申请人提供)：尼古丁依赖日益被认为是一种复杂和慢性的疾病。在接受戒烟干预的吸烟者中，只有10%-20%的人能够保持戒烟1年。戒烟计划的不良结果可能是由于大多数现有的行为治疗作为药物治疗的补充，其简短和强度有限。在我们的实验室中，我们发现吸烟者接受高强度、高剂量的个体化尼古丁贴片治疗，同时只进行非常少量的行为咨询，戒烟率非常低(14%)。我们提出了一项研究，将使用随机、谨慎控制的实验设计，检查使用中等强度的延长咨询方案是否会显著提高戒断率。我们的研究将提供我们所知的关于在接受尼古丁替代治疗的人中最大限度地提高戒烟率所需的最佳咨询持续时间的第一信息。我们将招募450名吸烟者，并提供为期12周的尼古丁贴片治疗。受试者将被随机分配到以下戒烟后咨询条件之一：(A)12周，(B)24周，或(C)52周。我们的研究将为Hall等人最近的开创性工作提供一个复制和重要的扩展。(Hall等人，Am J精神病学2004；161：2100-2107)发现，在一个小样本中，52周的延长咨询方案产生了50%-55%的1年戒烟率。我们将确定在更严重依赖的吸烟者的大样本中，延长咨询方案的使用是否可以在戒烟后1年获得类似的戒烟率。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，或者更短的持续时间(6个月)是否可能与吸烟者更容易接受的治疗方案一样有效，或者几乎一样有效。此外，我们将研究延长持续时间咨询可能增加戒烟率的机制(例如，社会支持)，并跟踪吸烟者2年，以评估那些被随机分配到更长持续时间咨询条件的人在第一年假设的较高戒烟率的持久性。次级目标将检查延长持续时间的咨询是否对某些亚群特别有益，如妇女、教育程度较低的人和有抑郁症状的人。我们还将提供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，这可能有助于制定未来特定时间的治疗干预措施。如果我们关于长期咨询有效性的主要假设得到支持，这将表明，为了减少美国日益顽固的吸烟者中吸烟的流行率，可能需要一种新的治疗模式，包括更频繁和更有条理的接触，更长的观察时间，以及在复发时再次戒烟的尝试。项目叙述复发(重返吸烟)发生在大多数试图戒烟的吸烟者(大约80%-95%)。我们的研究将测试使用延长持续时间的咨询程序在更严重依赖的吸烟者中改善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.