Extended Treatment for Smoking Cessation

描述（由申请人提供）：研究表明，药物成瘾是一种慢性、复发性疾病，需要延长治疗和随访。然而，只有少数戒烟试验研究了扩展治疗模式的效用。我们建议检查多组分扩展戒烟治疗在促进长期戒烟方面的疗效。成年吸烟者和青少年吸烟者（18 - 21岁）将作为本研究的目标人群。共400名吸烟者将接受随机化。治疗将包括开放标签和扩展治疗期。开放标签治疗。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）和个性化的认知和行为技能培训（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。那些对安非他酮和尼古丁贴片无效的人将在第26周之前改用伐尼克兰。那些超过10周复发的人将重新开始安非他酮和尼古丁贴片，直到26周。延长治疗。开放标签治疗后，一半（n=200）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，电话咨询将结合语音信箱、计算机和手机技术提供，以便监测治疗计划的执行情况，及早发现吸烟“失误”，并由治疗人员迅速作出反应。控制其余受试者（n=200）将从第26周至第52周每月接受电话支持。这项拟议的研究将解决我们对有效戒烟治疗知识的几个重要空白。首先，这将是为数不多的几项研究之一，旨在调查延长戒烟治疗的效果。其次，这将是第一个对照研究，以检查多组分治疗的效果，采用药物治疗，强化行为技能培训，自助技能培训和快速检测和通过语音邮件，手机和电话咨询的反应。 公共卫生相关性：吸烟是一个重大的公共卫生问题。本研究旨在研究延长戒烟治疗的有效性。

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.