Secondary Analyses of Clinical Trial Data to Understand Factors Associated with Alcohol Use Among Alaska Native Populations

项目概要/摘要 本项目提案反映了一项合作和协调的培训和研究计划， 申请人向成为阿拉斯加原住民（AN）独立酒精研究员的过渡 社区.即，提出了四个培训目标：1）培养酒精治疗和临床方面的专业知识 在AN人群中进行试验研究; 2）熟练掌握创伤应激研究和 酒精使用的创伤; 3）获得方法和先进的定量技能， 设计和分析临床试验;和4）进一步发展科学写作技能，加强出版 记录，并专业成长为酒精研究人员和该领域未来的领导者。这些技能将 应用于执行拟议项目，检查两个随机对照试验数据集， 酒精使用障碍（AUD）、问题性饮酒、吸烟、创伤、文化和生活质量（QOL）。临床 试验数据将来自（1）纳洛酮研究39，一项纳洛酮和舍曲林治疗以下疾病的临床试验： AN和非本地样本中的AUD;以及（2）HEALTHH研究42，一项针对以下人群的临床试验： 吸烟，包括两种促进心脏健康的干预措施（a）戒烟和身体健康 活动和（B）药物依从性和心脏健康AN饮食。研究检查AN表示， 1986年至2005年间，针对主要精神障碍的临床试验发现， 来自美洲印第安人（AI）或AN遗产5。此外，2014年对AI/AN进行了详尽的文献检索， 心理健康治疗干预只导致了两项临床试验。这比考虑到 事实上，AN人经历了不成比例的高比率的澳元，有问题的饮酒，酒精相关的 伤害和死亡、吸烟、健康差距、创伤后应激障碍和创伤后应激障碍的高发病率以及系统性种族主义 2，5，12，16，25，48.这些因素影响了AN文化，健康和酒精治疗的结构 获取、利用和结果8，13，23.因此，本项目将探讨创伤、吸烟和 文化影响饮酒和QOL结果。目的1是研究酒精使用的预测因素和调节因素， 使用纳洛酮研究的数据，纳洛酮在AN患者中的治疗效果，目的2是检查 饮酒对两种针对不同文化的干预措施的有效性的影响， 心血管健康和这些干预措施对AN人群饮酒的影响，使用的数据来自 健康研究。这些目标产生的数据有可能确定 与AN人群中酒精使用，治疗和结果相关的因素，这对公共卫生具有重要意义 重要性此外，研究结果对发展创伤知情的，文化衍生的， 对AN患者进行多层次的酒精治疗干预。

Project Summary/Abstract This project proposal reflects a collaborative and coordinated training and research plan that will facilitate the applicant’s transition towards becoming an independent alcohol researcher within Alaska Native (AN) communities. Namely, four training goals are proposed: 1) Develop expertise in alcohol treatment and clinical trials research within the AN population; 2) Obtain proficiency in traumatic stress research and the impact of trauma on alcohol use among AN people; 3) Acquire methodological and advanced quantitative skills for designing and analyzing clinical trials; and 4) Further develop scientific writing skills, strengthen publication record, and grow professionally as an AN alcohol researcher and future leader in the field. These skills will be applied to carrying out the proposed project of examining two randomized control trial datasets related to alcohol use disorder (AUD), problematic drinking, smoking, trauma, culture, and quality of life (QOL). Clinical trials data will be from (1) the Naltrexone Study39, a clinical trial of naltrexone and sertraline for the treatment of AUD among an AN and non-Native sample; and (2) the HEALTHH Study42, a clinical trial for people who smoke tobacco that includes two interventions to promote heart health (a) tobacco cessation and physical activity and (b) medication adherence and a heart healthy AN diet. Research examining AN representation in clinical trials for major mental disorders between 1986 and 2005 found that not one of the 10,000 participants were from American Indian (AI) or AN heritage5. Moreover, an exhaustive literature search in 2014 of AI/AN mental health treatment intervention resulted in only two clinical trials. This is more than troublesome given the fact that AN people experience disproportionately high rates of AUD, problematic drinking, alcohol-related injury and death, smoking, health disparities, high rates of PTSD and traumatic stress, and systemic racism and oppression2,5,12,16,25,48. These factors impact the very fabric of AN culture, wellbeing, and alcohol treatment access, utilization, and outcomes8,13,23. Thus, this project will explore the extent to which trauma, smoking, and culture impacts drinking and QOL outcomes. Aim 1 is to examine predictors of alcohol use and moderators of naltrexone treatment effects among AN people using data from the Naltrexone Study and Aim 2 is to examine the impact of drinking on the efficacy of two culturally tailored interventions targeting modifiable risks for cardiovascular health and the effects of these intervention on drinking among AN people using data from The HEALTHH Study. Resultant data from these aims have the potential to identify the nature and impacts of factors associated with alcohol use, treatment, and outcomes among AN people, which is of great public health importance. Additionally, the results have implications for developing trauma-informed, culturally derived, multilevel alcohol treatment interventions for AN people.