Extended Treatment for Smoking Cessation

描述(申请人提供)：研究表明，吸毒成瘾是一种慢性、复发性疾病，需要长期治疗和随访。然而，只有少数戒烟试验检验了扩展治疗模式的实用性。我们建议研究一种多组分的长期戒烟疗法在促进长期戒烟方面的效果。成人吸烟者和18-21岁的青少年吸烟者将作为本研究的目标人群。总共有400名吸烟者将被随机分配。治疗将包括开放标签和延长治疗阶段。开放式标签治疗。所有400名吸烟者将接受尼古丁贴片(21毫克)、安非他酮(300毫克)和个性化认知和行为技能训练(ST)。尼古丁贴片和安非他酮将提供10周，认知行为治疗(CBT)将提供26周。对安非他酮和尼古丁贴片无效的患者将在第26周期间改用varenicline。那些复发超过10周的人将在第26周重新开始安非他酮和尼古丁贴片。延长治疗时间。在开放标签治疗后，一半(n=200)患者将从第26周至第52周接受CBT。CBT将包括治疗师指导和自我指导的复发预防技能培训。此外，将结合语音信箱、计算机和手机技术提供电话咨询，使治疗人员能够监测治疗计划的执行情况，及早发现吸烟“失误”并做出快速反应。控制室。其余参与者(n=200)将在第26周至第52周期间每月接到电话支持电话。这项拟议的研究将解决我们在有效戒烟治疗方面知识上的几个重要空白。首先，这将是少数几项研究之一，以调查延长戒烟疗法的效果。其次，这将是首批对照研究之一，旨在检验采用药物疗法、强化行为技能训练、自助技能训练以及通过语音信箱、手机和电话咨询快速检测和反应滑倒的多组分治疗的效果。 与公共健康相关：吸烟是一个主要的公共健康问题。这项研究旨在研究长期戒烟治疗的效果。

DESCRIPTION (provided by applicant): Research indicates that drug addictions are chronic, relapsing disorders requiring extended therapy and follow-up. However, only a few smoking cessation trials have examined the utility of extended therapy models. We propose to examine the efficacy of a multi-component extended cigarette smoking cessation treatment in promoting longer-term smoking abstinence. Adult smokers and adolescent smokers (18 - 21) years of age will serve as the target population for this study. A total of 400 smokers will be randomized. Treatment will include both open label and extended treatment phases. Open Label Treatment. All 400 smokers will receive nicotine patch (21mg), bupropion (300mg) and individualized cognitive and behavioral skills training (ST). Nicotine patches and bupropion will be provided for 10 weeks and cognitive behavior therapy (CBT) will be provided for 26 weeks. Those who fail to respond to bupropion and nicotine patch will be switched to varenicline through week 26. Those who relapse beyond week 10 will re-start bupropion and nicotine patch through week 26. Extended Treatment. Following open label treatment, half (n=200) will receive CBT from week 26 - week 52. CBT will include both therapist-directed and self-directed relapse prevention skills training. In addition, telephone counseling will be provided in conjunction with voicemail, computer and cell phone technology enabling monitoring of treatment plan implementation and early detection of smoking "slips" and rapid response by treatment staff. Control. Remaining participants (n=200) will receive monthly telephone support calls from week 26 - week 52. The proposed study will address several important gaps in our knowledge of effective smoking cessation treatment. First, this will be one of only a handful of studies to investigate the effects of extended therapy for smoking cessation. Second, this will be among the first controlled studies to examine the effects of a multi-component treatment employing pharmacotherapy, intensive behavioral skills training, self-help skills training and rapid slip detection and response via voicemail, cell phone and telephone counseling. PUBLIC HEALTH RELEVANCE: Cigarette smoking is a major public health problem. This study is designed to study the efficacy of an extended smoking cessation treatment.