Abstinence Reinforcement Therapy (ART) for Homeless Veteran Smokers

描述(由申请人提供)： 项目背景。无家可归的退伍军人吸烟率(80%)比美国总人口(20%)高得多，因此吸烟致死的风险增加。包括尼古丁替代疗法(NRT)等戒烟辅助手段在内的戒烟治疗远远没有得到充分利用，特别是在无家可归的资深吸烟者中。特别需要针对无家可归的退伍军人制定有效的干预措施。无家可归的退伍军人明显不太可能获得以诊所为基础的强化戒烟护理。虽然我们小组和其他人的努力已经将戒烟治疗的范围扩大到临床之外，包括远程医学、认知行为电话咨询和基于互联网的干预，但有人建议，需要更具创新性和集约化的戒烟方法，以提高戒烟率，特别是在无家可归的退伍军人中。强化行为疗法的使用，如应急管理(CM)，可能是无家可归退伍军人戒烟干预的有用组成部分。在其他难以治疗的人群中，CM已经显示出减少吸烟的有效性。项目目标。目前这项研究的主要目标是在一项针对无家可归的资深吸烟者的随机对照试验中，评估将基于证据的戒烟治疗与基于智能手机的便携式吸烟率应急管理相结合的干预措施的有效性，并与VA戒烟专门护理干预措施进行比较。具体地说，126名退伍军人将随机接受戒烟强化疗法(ART)，该疗法结合了基于证据的认知行为电话咨询、获得NRT的远程医疗诊所和移动应急管理(MCM)，或接受VA戒烟专门护理干预。具体目标和假设是：目的1：调查ART对治疗后、治疗后3个月和6个月随访的戒烟率的影响。假设1：随机接受ART干预的退伍军人的戒烟率将显著高于随机接受退伍军人戒烟专科护理控制的退伍军人。目的2：评价抗逆转录病毒治疗干预的相对成本-效果。假设2：与对照条件相比，基于ART的治疗将产生更大的成本效益，以增量成本-效果比衡量。目的3：评估潜在的治疗中介因素，包括自我效能相关机制。假设3：与VA专科护理对照条件相比，与ART相关的节欲增加将部分通过提高自我效能感来调节。项目方法和预期结果。拟议的是一个为期四年的项目，126名无家可归的资深吸烟者将被随机分配到接受多成分戒烟强化疗法或退伍军人管理局特殊护理控制干预。参与研究的患者将在治疗后、随机化后3个月和6个月接受调查。试验的主要结果是在6个月的随访中自我报告长期戒酒，并通过可替宁试验进行验证。预计抗逆转录病毒治疗将提高无家可归退伍军人的戒烟率，与专门护理相比，将与更高的成本效益相关。

DESCRIPTION (provided by applicant): Project Background. Homeless Veterans smoke at an inordinately high rate (80%) compared to the general U.S. population (20%), and thus are at increased risk for the lethal effects of cigarette smoking. Smoking cessation treatment including smoking cessation aids such as nicotine replacement therapy (NRT) are greatly underutilized, particularly among homeless Veteran smokers. There is a special need to develop effective interventions that target homeless Veterans. Homeless Veterans are significantly less likely to access intensive clinic-based smoking cessation care. While the efforts of our group and others have expanded the reach of smoking cessation treatment options beyond the clinic to include tele-medicine, cognitive-behavioral telephone counseling, and internet based interventions, it has been suggested that there is a need for more innovative and intensive approaches to smoking cessation in order to improve quit rates, particularly among homeless Veterans. The use of intensive behavioral therapies, such as contingency management (CM), may be a useful component for smoking cessation interventions among homeless Veterans. CM has shown efficacy for reducing smoking in other difficult-to-treat populations. Project Objectives. The primary goal of the current study is to evaluate the effectiveness of an intervention that combines evidenced-based treatment for smoking cessation with smart-phone based, portable contingency management on smoking rates compared to a VA smoking cessation specialty care intervention in a randomized controlled trial among homeless Veteran smokers. Specifically, 126 Veterans will be randomized to receive Abstinence Reinforcement Therapy (ART) which combines evidenced based cognitive-behavioral telephone counseling, a tele-medicine clinic for access to NRT, and mobile contingency management (mCM), or to receive VA smoking cessation specialty care intervention. The specific aims and hypotheses are: AIM 1: To investigate the impact of ART on rates of abstinence from cigarettes at post-treatment, 3-month and 6- month post-treatment follow-ups. Hypothesis 1: Abstinence rates will be significantly higher among Veterans randomized to the ART-based intervention than those randomized to the VA smoking cessation specialty care control arm. AIM 2: To evaluate the relative cost-effectiveness of the ART intervention. Hypothesis 2: ART based treatment will result in greater cost-effectiveness compared to the control condition as measured by the incremental cost- effectiveness ratio. AIM 3: To assess potential treatment mediators including self-efficacy-related mechanisms. Hypothesis 3: Increased abstinence associated with ART will be partially mediated by increased self-efficacy compared to the VA specialty care control condition. Project Methods and Expected Results. Proposed is a four year project in which 126 homeless Veteran smokers will be randomized to receive either a multi-component Abstinence Reinforcement Therapy or a VA specialty care control intervention. Participating patients will be surveyed at post-treatment, 3-months and 6- months post-randomization. The primary outcome of the trial is prolonged self-reported abstinence at the 6-month follow-up, verified by cotinine assay. It is expected that ART will improve quit rates among homeless Veterans, and compared to specialty care, will be associated with greater cost-effectiveness.