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

针对患有酒精使用障碍的吸烟者的基于成瘾神经临床评估的治疗

基本信息

批准号：
10665543
负责人：
Sterling M McPherson
金额：
$ 56.25万
依托单位：
WASHINGTON STATE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-05-01 至 2026-04-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10665543
关键词：
2 arm randomized control trial Address Aftercare Alcohol consumption Alcohols Behavior Therapy Behavioral Biochemical Cigarette Clinical Combined Modality Therapy Communities Consumption Control Groups Cotinine Counseling Dangerousness Drug abuse Drug usage Emotional Executive Dysfunction Future Glucuronides Health Healthcare Heavy Drinking Intervention Investigation Letters Measures Mediator Modality Outcome Participant Patient Self-Report Patients Persons Pharmacotherapy Pilot Projects Population Psychiatry Psychological reinforcement Public Health Randomized Research Risk Severities Smoker Smoking Smoking Cessation Intervention Subgroup Testing Time Tobacco Tobacco use United States Urine Validation addiction alcohol abuse therapy alcohol comorbidity alcohol measurement alcohol use disorder behavior change behavioral study biological sex cigarette smoking clinical trial analysis clinically relevant cognitive function contingency management editorial eligible participant emotional functioning evidence base executive function experience follow-up group intervention incentive salience innovation neurochemistry personalized medicine point of care preventable death primary outcome recruit reduced alcohol use secondary analysis secondary outcome smoking cessation smoking initiation sound synergism tobacco smokers treatment as usual treatment duration treatment group treatment response treatment strategy two-arm trial varenicline

项目摘要

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.

项目概要/摘要在美国，烟草和酒精每年导致超过 50 万人死亡，这使得对这些物质的成瘾是可预防的死亡的主要原因。我们建议采取应急管理措施。 (CM) 范式基于测量乙基葡萄糖醛酸苷的即时尿检。成瘾神经临床评估（ANA），在核心领域（即激励显着性、消极情绪和认知功能），并从健全和创新的科学出发前提是，我们将首次通过实施基于证据的行为来针对吸烟和饮酒对已开始一线药物治疗（伐尼克兰；VC）的参与者进行酒精治疗（CM）该项目旨在复制、利用和扩展我们之前的中学研究结果。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我们将通过向同时吸烟的人提供饮酒的 CM 来实现这一目标。我们还寻求确定最有效的基于 ANA 的介质。（例如，考虑到 CM 的重点是替代强化，激励显着性）响应行为的改变最后，我们将检查生物性别与基线饮酒和吸烟的程度。吸烟与 CM 相互作用，可不同程度地减少患者饮酒和吸烟。参加一项 2 臂随机对照试验，以评估 CM 干预减少饮酒的能力完成两周的诱导期后，患者将被随机分为 2 个试验组。 12周治疗期：1）CM干预组照常接受戒烟治疗 (TAU)，其中包括伐尼克兰和咨询，以及 2) 非偶然 (NC) 对照组，该对照组也接受 TAU。我们的具体目标是：1) 确定 CM+TAU 是否比 NC+TAU 更有效地减少酒精摄入。我们努力争取 CM 会降低经生化验证的酒精使用率。吸烟、同时经生化验证的饮酒和吸烟以及自我报告的饮酒情况在 12 周的治疗和 6 个月的随访期间，每天吸烟的天数、每天吸烟的天数和酗酒的天数。 3) 确定治疗组中最有效的基于 ANA 的治疗反应调节因子。升高高级执行功能障碍、负面情绪以及与酒精和吸烟相关的激励显着性将与治疗期间和治疗期间较高水平的饮酒和吸烟有关 3) 确定生物性别或饮酒和吸烟的基线严重程度是否与治疗相互作用分配给我们的主要和次要结果产生不同的变化。生物性别将与治疗显着相互作用，从而产生不同的结果，而那些生物性别较少的人基线饮酒和吸烟的严重程度将得到更好的结果，这项调查将支持。未来的研究可以确定针对 AUD 吸烟者不同亚组的个性化治疗。