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

对临床试验数据进行二次分析，以了解与阿拉斯加原住民饮酒相关的因素

• 批准号: 10315800
• 负责人: Maria Christina Crouch
• 金额: $ 7.1万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-14 至 2024-07-13
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10315800
• 关键词: Address; Alaska Native; Alcohol abuse; Alcohol consumption; Alcohols; American Indians; Applications Grants; Area; Attention; Awareness; Belief; Cardiac health; Cardiovascular Diseases; Cessation of life; Clinical Trials; Communities; Data; Data Set; Death Rate; Development; Diabetes Mellitus; Diet; Ethics; Exercise; Fellowship; Future; Goals; Health; Health Services Accessibility; Health behavior; Healthcare; Healthy Eating; Heart; Holistic Health; Injury; Institutional Racism; Intervention; Investigation; Knowledge; Literature; Liver diseases; Logistic Regressions; Mental Health; Mental disorders; Methodology; Modeling; Morbidity - disease rate; Naltrexone; National Institute on Alcohol Abuse and Alcoholism; Native-Born; Nature; Outcome; Pain; Participant; Personal Satisfaction; Physical activity; Population; Post-Traumatic Stress Disorders; Prevalence; Public Health; Publications; Quality of life; Randomized; Recording of previous events; Recovery; Research; Research Personnel; Risk; Risk Behaviors; Role; Sampling; Sertraline; Severities; Smoker; Smoking; Smoking and Health Research; Stereotyping; Stigmatization; Survival Analysis; Textiles; Tobacco; Tobacco Use Cessation; Tobacco smoke; Training; Trauma; Treatment outcome; United States National Institutes of Health; Writing; alcohol abuse therapy; alcohol effect; alcohol intervention; alcohol related consequences; alcohol research; alcohol use disorder; alcohol-related injury; binge drinking; cardiovascular health; career; clinical trial analysis; control trial; design; drinking; exhaustion; experience; health disparity; improved; intervention effect; medication compliance; modifiable risk; non-Native; nutrition; physical conditioning; physical inactivity; premature; protective factors; resilience; secondary analysis; skills; social stigma; traumatic stress; treatment effect; treatment planning; treatment research; treatment trial

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.

项目概要/摘要 该项目提案反映了协作和协调的培训和研究计划，将促进 申请人向阿拉斯加原住民 (AN) 内的独立酒精研究员的转变 即，提出了四个培训目标： 1）发展酒精治疗和临床方面的专业知识。 AN 人群中的试验研究；2) 熟练掌握创伤应激研究及其影响 AN 人群饮酒造成的创伤；3) 获得以下方面的方法和高级定量技能： 设计和分析临床试验；4) 进一步培养科学写作技能，加强发表 这些技能将成为一名酒精研究人员和该领域的未来领导者的记录和专业成长。 应用于执行检查两个相关的随机对照试验数据集的拟议项目 酒精使用障碍 (AUD)、饮酒问题、吸烟、创伤、文化和生活质量 (QOL)。 试验数据将来自 (1) 纳曲酮研究39，这是一项纳曲酮和舍曲林治疗以下疾病的临床试验 AUD 在 AN 和非本地样本中；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的 AN 饮食 研究检查 AN 的表现。 1986 年至 2005 年间针对主要精神障碍的临床试验发现，10,000 名参与者中没有一个人 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。 心理健康治疗干预仅进行了两项临床试验，考虑到这一点，这实在是太麻烦了。 事实上，AN 人群的澳元、饮酒问题、与酒精相关的比例过高 伤害和死亡、吸烟、健康差异、创伤后应激障碍和创伤性应激的高发生率以及系统性种族主义 和压迫2,5,12,16,25,48 这些因素影响着AN 文化、福祉和酒精治疗的本质。 获取、利用和结果8,13,23 因此，该项目将探讨创伤、吸烟和治疗的程度。 文化对饮酒和生活质量结果的影响 目标 1 是检查饮酒的预测因素和饮酒的调节因素。 使用纳曲酮研究的数据来评估纳曲酮对 AN 人群的治疗效果，目标 2 是检查 饮酒对针对可改变的风险的两种针对文化的干预措施的功效的影响 使用以下数据研究心血管健康以及这些干预措施对 AN 人群饮酒的影响： 健康研究的结果数据有可能确定这些目标的性质和影响。 与 AN 人群饮酒、治疗和结果相关的因素，这对公共卫生具有重要意义 此外，这些结果对于发展创伤知情的、文化衍生的、 针对 AN 人群的多级酒精治疗干预措施。