Technological Innovations for the Remote Monitoring of Smoking in Adolescents

描述(由申请人提供)：麦克卢尔博士是南卡罗来纳医科大学(MUSC)精神病学和行为科学系临床神经科学部的[研究讲师]。麦克卢尔博士通过国家药物滥用研究所寻求导师研究科学家发展奖(K01)。该奖项将提供必要的培训，以促进她向独立的过渡，以追求专注于促进青少年戒烟的技术创新的研究议程。候选人。麦克卢尔博士是一名行为心理学家，在药物滥用研究和治疗领域接受过广泛的临床前和临床培训，特别关注烟草和大麻依赖。McClure博士需要通过K01奖项进行职业发展，以实现她专注于吸烟和复发的多学科研究以及这些知识如何为个性化、以患者为中心的治疗干预提供信息的长期目标。麦克卢尔博士为5年的K01奖金期精心设计了一份有条理的职业发展计划。麦克卢尔博士的目标将是：1)获得移动健康(MHealth)方面的培训，包括方法学、分析、工程学和隐私/保密方面的广泛知识；[2)获得纵向数据分析方面的生物统计学培训]；3)扩大对青少年戒烟和成瘾的了解；4)扩大对进行随机临床试验的理解；以及[5)提高拨款撰写技能，以成功过渡到研究独立性。]环境MUSC是一个协作、富有成效的环境，将为McClure博士通过K01奖项接受职业发展指导提供理想的环境。研究效率非常高，2012财年发放了1242笔校外补助金，总额超过2.32亿美元。墨尔本南加州大学有很强的成瘾重点，在药物和酒精滥用医学教育方面跻身全国十大医学院之列。超过30名教职员工参与了跨部门和跨学科的成瘾培训和研究。精神病学和行为科学系在美国国立卫生研究院精神病学系的研究经费中排名第七，2012财年，教职员工获得173项拨款和合同，总额为4,080万美元。所有研究程序将通过临床神经科学部(CND；主任，麦克雷-克拉克)进行，候选人、主要导师(Gray)和共同导师(Brady)在那里进行预约。国家研究中心为研究程序的成功实施提供了基础设施和专用空间。技术专长、培训和软件开发将由加州大学洛杉矶分校护理学院内的健康生活方式技术应用中心(TACHL)提供，该中心由Frank Treiber博士(共同导师)指导。[生物统计学培训和课程将通过公共卫生科学系提供，候选人的共同导师(Ramakrishnan)将在那里进行预约。]MUSC通过南卡罗来纳州临床和翻译研究所以及研究发展办公室和赞助项目研究办公室为早期职业研究人员提供多种资源，如试点基金、研讨会、赠款撰写课程和咨询、模拟研究部分以及研究和招聘服务。在美国，吸烟是可预防的死亡的主要原因，绝大多数成年吸烟者在18岁之前就开始吸烟。了解戒烟过程中复发的过程对于开发高效的治疗干预措施至关重要，但人们对吸烟复发的自然历史知之甚少。 青少年吸烟者。主要不依赖自我报告的远程监测吸烟的技术创新将能够对复发进行精细的分析，这可能是一种非常富有成效的探索途径。这项K01申请中的研究建议开发和评估一个综合的远程监测系统，该系统结合了通过生态瞬时评估(EMA)对吸烟的自我报告和通过呼气一氧化碳(CO)对青少年(14-21岁)吸烟的生化验证。在目标1中，将通过定量和定性方法(实验1)在吸烟1周期间评估EMA+CO系统的可行性、可接受性和依从性。然后，实验2将监测戒烟尝试后再次吸烟的情况，并将EMA+CO系统与传统EMA单独使用以及每周进行临床检查进行比较，以获得吸烟的生化验证。在目标2中，将比较不同组别中一氧化碳和自我报告吸烟之间的一致性。与EMA单独组相比，EMA+CO组的参与者在自我报告吸烟和CO验证之间表现出更高的一致性。此外，在探索性目标1中，戒烟尝试后复发的轨迹将跨组表征。最后，在探索性目标2中，将比较吸烟和非吸烟场合的情景状态和瞬间状态的EMA评分。对吸烟的远程监测允许对行为过程进行细粒度的表征，而不是可能无法捕捉到复发的复杂过程的结果。对这一系统的评估是最终目标的关键的第一步，目的是促进将其用于未来的研究，以回答有关复发的问题。然后，这些知识可以在关键时刻提供最有效的、及时的干预措施，以促进长期禁欲。

DESCRIPTION (provided by applicant): Dr. McClure is a [Research Instructor] in the Clinical Neuroscience Division of the Department of Psychiatry and Behavioral Sciences at the Medical University of South Carolina (MUSC). Dr. McClure seeks a Mentored Research Scientist Development Award (K01) through the National Institute on Drug Abuse. This award will provide the essential training to facilitate her transition to independence to pursue a research agenda focused on technological innovations to advance smoking cessation in adolescents. Candidate. Dr. McClure is a behavioral psychologist with extensive preclinical and clinical training in the areas of substance abuse research and treatment, with a specific focus on tobacco and cannabis dependence. Dr. McClure requires career development through the K01 award in order to realize her long-term goals focused in the multidisciplinary research of smoking and relapse and how that knowledge can inform personalized, patient-centered treatment interventions. Dr. McClure has carefully devised a structured career development plan for the 5-year K01 award period. Dr. McClure's objectives will be to: 1) obtain training in mobile health (mHealth), including extensive knowledge of methodology, analyses, engineering, and privacy/confidentiality concerns; [2) obtain biostatistical training in the analysis of longitudina data]; 3) broaden understanding of adolescent smoking cessation and addiction; 4) expand understanding in conducting randomized clinical trials; and [5) improve grant writing skills to successfully transition to research independence.] Environment. MUSC is a collaborative, productive environment that will provide the ideal setting for Dr. McClure to receive mentored career development through the K01 award. Research productivity is stellar, with 1,242 extramural grants awarded during FY2012, totaling more than $232 million. MUSC has a strong addictions focus, and ranks among the top 10 medical schools in the country for drug and alcohol abuse medical education. Over 30 faculty are engaged in training and research in addiction across departments and disciplines. The Department of Psychiatry and Behavioral Sciences ranks 7th in NIH research funding among domestic psychiatry departments, with faculty receiving 173 grant and contract awards, totaling $40.8 million in FY2012. All study procedures will take place through the Clinical Neuroscience Division (CND; Director, McRae-Clark), where the candidate, Primary Mentor (Gray) and Co-Mentor (Brady) hold appointments. The CND provides the infrastructure and dedicated space for successful execution of study procedures. Technological expertise, training, and software development will be provided by the Technology Applications Center for Healthful Lifestyles (TACHL) within the School of Nursing at MUSC, which is directed by Dr. Frank Treiber (Co-Mentor). [Biostatistical training and coursework will be provided through the Department of Public Health Sciences, where the candidate's Co-Mentor (Ramakrishnan) holds an appointment.] MUSC offers several resources to Early Career Investigators, such as pilot funds, seminars, grant writing courses and consultations, mock study sections, and research and recruitment services through the South Carolina Clinical and Translational Research Institute and the Offices of Research Development and Sponsored Programs Research. Cigarette smoking is the leading cause of preventable death in the US, with the vast majority of adult smokers starting prior to age 18. Understanding the process of relapse to smoking during a quit attempt is critical for the development of highly efficacious treatment interventions, yet little is known about the natural history of relapse among adolescent smokers. Technological innovations for the remote monitoring of smoking that do not primarily rely on self-report would allow for the fine-grained analysis of relapse and may be a highly fruitful avenue to explore. The studies in this K01 application propose to develop and evaluate a comprehensive remote monitoring system combining self-reports of smoking through ecological momentary assessment (EMA) with biochemical verification of smoking through breath carbon monoxide (CO) in adolescents (ages 14-21). In Aim 1, feasibility, acceptability, and compliance of the EMA + CO system will be evaluated during 1 week of smoking through quantitative and qualitative methods (Experiment 1). Experiment 2 will then monitor relapse to smoking following a quit attempt and compare the EMA + CO system vs. traditional EMA alone plus weekly clinic visits to obtain biochemical verification of smoking. In Aim 2, agreement between CO and self-reported smoking across groups will be compared. Participants in the EMA + CO group are expected to exhibit higher agreement between self-reported smoking and CO verification compared to the EMA alone group. Additionally, in Exploratory Aim 1, the trajectory of relapse following a quit attempt will be characterized across groups. Finally, in Exploratory Aim 2, EMA ratings of situational and momentary states will be compared during smoking and non-smoking occasions. The remote monitoring of smoking allows for the fine-grained characterization of behavioral processes, rather than outcomes that may not capture the complex process of relapse. The evaluation of this system is a critical first step in the eventual goal of facilitating its use for future studies to answer questions regarding relapse. Thi knowledge can then inform maximally effective, just-in-time interventions delivered at critical moments to promote long-term abstinence.