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。在接受戒烟干预的吸烟者中，只有10-20%的人能够保持1年的戒烟。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性和有限的强度。在我们的实验室里，我们发现吸烟者在接受密集的、大剂量的个体化尼古丁贴片治疗的同时，只进行很少的行为咨询，戒烟率非常低（14%）。我们建议进行一项研究，采用随机、精心控制的实验设计，检验使用中等强度的长时间咨询方案是否会显著提高戒烟率。我们的研究将为我们提供第一个信息，关于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咨询的最佳持续时间。我们将招募450名吸烟者作为样本，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周的咨询。我们的研究将提供Hall et al. （Hall et al., Am J Psychiatry 2004;161:2100-2107）最近开创性工作的复制和重要扩展，该研究发现，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。我们将确定在大量重度依赖吸烟者的代表性样本中，使用延长时间的咨询方案是否可以在戒烟后1年获得相似的戒烟率。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，或者更短的治疗时间（6个月），可能更容易被吸烟者接受，可能同样有效，或几乎同样有效。此外，我们将研究延长咨询时间可能增加戒烟率的机制（如社会支持），并对吸烟者进行为期2年的随访，以评估那些随机分配到延长咨询时间条件的吸烟者在第一年假设的较高戒烟率的持久性。次要目的是研究延长咨询时间是否对某些亚群体（如妇女、受教育程度较低的人群和有抑郁症状的人群）特别有益。我们还将提供有关吸烟者在戒烟后不同时期所经历的困难的信息，这些信息可能有助于制定未来针对特定时间的治疗干预措施。如果我们关于长时间咨询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，包括更频繁和有组织的接触，更长的观察时间，以及在复发的情况下重新尝试戒烟，可能是必要的，以减少美国日益顽固的吸烟者中吸烟的流行。大多数试图戒烟的吸烟者（大约80-95%）都会复发（重新吸烟）。我们的研究将测试使用长时间咨询程序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出能够增加吸烟者成功戒烟可能性的治疗方法。

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.