An Addictions Neuroclinical Assessment Based Treatment for Smokers with an Alcohol Use Disorder

项目摘要/摘要 在美国，烟草和酒精每年总共导致50多万人死亡，使 对这些物质的上瘾是可预防死亡的主要原因。我们提出了应急管理方案 (Cm)以测量乙基葡萄糖醛酸乙酯的护理点尿液测试为基础的范例。理论上被框定在 核心领域(即激励)假想机制的成瘾神经临床评估(ANA) 突出、消极情绪和认知功能)，并从健全和创新的科学 前提下，我们将第一次针对吸烟和酒精使用，通过实施基于证据的行为 已开始一线药物治疗(varenicline；VC)的参与者的酒精治疗(CM) 为了戒烟。该项目寻求复制、利用和扩展我们以前的研究结果 分析和试点研究表明，应用CM来针对酒精的使用可以产生非 有针对性地减少吸烟。我们将通过向同时吸烟者提供饮酒CM来实现这一点 启动戒烟药物治疗。我们还试图确定最有力的以ANA为基础的调解人 (例如，考虑到CM的重点是替代强化)作为响应的行为改变的激励性 去接受治疗。最后，我们将检查生物性行为、基线酒精使用和吸烟的程度 吸烟与CM相互作用，产生不同程度的减少饮酒和吸烟。患者会 参加一项双臂随机对照试验，以评估CM干预减少酒精使用的能力 还有抽烟。在完成为期两周的引导期后，患者将被随机分成两个试验组 治疗12周：1)CM干预组，照常接受戒烟治疗 (Tau)，包括varenicline和咨询；2)非偶发(NC)对照组，也接受 陶先生。我们的具体目标是：1)确定CM+TAU在减少酒精方面是否比NC+TAU更有效 使用和吸烟。我们假设CM将产生较低的生物化学验证的酒精使用率 吸烟，同时进行生物化学验证的饮酒和吸烟，以及自我报告的饮酒 在12周的治疗期间和6个月的随访期内，每天吸烟和大量饮酒。 3)确定治疗组中最有效的基于ANA的治疗反应介体。我们 假设较高的执行功能障碍、负面情绪性以及与酒精和吸烟相关的激励 显著与酒精使用和吸烟水平较高有关，在治疗期间及以后 时间；3)确定生物性行为或酒精使用和吸烟的基线严重程度是否与治疗相互作用 任务是在我们的主要和次要结果中产生不同的变化。我们假设 生物性行为将显著地与治疗相互作用，以产生不同的结果，而那些 酒精使用和吸烟的严重程度达到基线将经历更好的结果。这项调查将支持 未来的研究可以确定对患有AUD的不同吸烟者亚群进行个性化治疗。

PROJECT SUMMARY/ABSTRACT Together, tobacco and alcohol kill more than half a million people in the United States every year, making co- addiction to these substances the leading cause of preventable death. We propose a contingency management (CM) paradigm based on point-of-care urine tests that measure ethyl glucuronide. Theoretically framed within the Addiction Neuroclinical Assessment (ANA) with hypothesized mechanisms in core domains (i.e., incentive salience, negative emotionality and cognitive function), and proceeding from a sound and innovative scientific premise, we will, for the first time, target smoking and alcohol use by implementing an evidence-based behavioral treatment (CM) for alcohol among participants who have initiated frontline pharmacotherapy (varenicline; VC) for smoking cessation. This project seeks to replicate, harness and extend our previous findings from secondary analyses and pilot studies, which demonstrate that applying CM to target the use of alcohol can produce non- targeted reductions in smoking. We will do so by offering CM for alcohol use to smokers who are simultaneously initiating smoking cessation pharmacotherapy. We also seek to identify the most potent ANA-based mediators (e.g., incentive salience given that CM’s focus is on alternative reinforcement) of behavior change in response to treatment. Lastly, we will examine the extent to which biologic sex and baseline alcohol use and cigarette smoking interacts with CM to produce different levels of reduced alcohol use and cigarette smoking. Patients will take part in a 2-arm randomized controlled trial to evaluate the ability of a CM intervention to reduce alcohol use and cigarette smoking. After completing a 2-week induction period, patients will be randomized into 2 trial arms for a 12-week treatment period: 1) a CM intervention group that receives smoking cessation treatment as usual (TAU), which includes varenicline and counseling, and 2) a non-contingent (NC) control group that also receives TAU. Our Specific Aims are to: 1) Determine if CM+TAU is more effective than NC+TAU for reducing alcohol use and cigarette smoking. We hypothesize that CM will yield lower rates of biochemically-verified alcohol use and cigarette smoking, concurrent biochemically-verified alcohol use and smoking, and self-reported drinks per day, cigarettes per day, and heavy drinking days during the 12-week treatment and 6-month follow-up periods. 3) Identify the most potent ANA-based mediators of treatment response across the treatment groups. We hypothesize that higher executive dysfunction, negative emotionality, and alcohol- and smoking-related incentive salience will be associated with higher levels of alcohol use and cigarette smoking across treatments and over time; 3) Determine if biological sex or baseline severity of alcohol use and smoking interacts with treatment assignment to produce differential changes in our primary and secondary outcomes. We hypothesize that biological sex will significantly interact with treatment to produce differential outcomes, and that those with less severity of alcohol use and smoking at baseline will experience better outcomes. This investigation will support future studies that can identify personalized treatment for different sub-groups of smokers with an AUD.