Mentored Patient-Oriented Research on Adolescent Alcohol Misuse and Treatment

指导以患者为导向的青少年酒精滥用和治疗研究

基本信息

批准号：
10198650
负责人：
ROBERT MIRANDA
金额：
$ 18.56万
依托单位：
BROWN UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-07-01 至 2023-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10198650
关键词：
21 year old Address Adolescence Adolescent Adult Aftercare Alcohol abuse Alcohol consumption Alcohols Behavior Therapy Behavioral Biological Assay Brain Brain Diseases Characteristics Chronic Clinical Clinical Investigator Clinical Trials Cognitive Therapy Collection Consumer Satisfaction Controlled Clinical Trials Data Development Ecological momentary assessment Enrollment Environment Etiology FDA approved Frequencies Functional disorder Funding Goals Gold Heavy Drinking Human Impairment Intervention Intoxication Investigational Therapies Knowledge Laboratories Laboratory Research Measures Mentors Method Acceptability Methods Mid-Career Clinical Scientist Award (K24)Modeling Motivation Neurocognitive Neurosciences Norepinephrine Outcome Participant Pathogenesis Pathogenicity Pharmaceutical Preparations Pharmacology Pharmacotherapy Phase Phenotype Physiological Placebos Prevalence Process Psychophysiology Randomized Randomized Clinical Trials Recording of previous events Research Research Personnel Rewards Risk Safety Science Scientist Severities Stimulus Stress Teenagers Testing Time Training Translating Translational Research United States Withdrawal Work Youth addiction adolescent alcohol misuse adolescent alcohol treatment adolescents with alcohol use disorders alcohol abuse therapy alcohol craving alcohol cue alcohol effect alcohol exposure alcohol misuse alcohol sensitivity alcohol use disorder atomoxetine binge drinking cost efficient craving critical period cue reactivity direct patient care drinking efficacy evaluation executive function hazardous drinking improved in vivo incentive salience inhibitor/antagonist innovation instrument mortality motivational processes neurobehavioral neurotoxic next generation novel outcome prediction patient oriented research pre-clinical programs psychosocial real world application reduced alcohol use research and development response responsible research conduct reuptake reward processing theories treatment effect treatment optimization underage drinking

项目摘要

PROJECT SUMMARY/ABSTRACT This K24 midcareer research and mentoring program aims to provide the candidate with protected time from direct patient care to conduct patient-oriented research (POR) on adolescent alcohol misuse and to mentor junior clinical investigators in translational research in addiction science. Understanding how behavioral, physiological, and neurocognitive assays measured in controlled laboratory settings can be leveraged to advance knowledge of how medications impact alcohol use in the real world requires expertise in clinical and behavioral neuroscience, psychophysiology, and clinical trials methods. For nearly two decades, the candidate has built a productive and continuously funded POR program that translates theory-driven hypotheses from preclinical and human laboratory research to real world applications. The proposed integrated plan will facilitate the candidate’s ability to mentor junior clinical investigators in POR and augment his capabilities as an independent clinician scientist. The research plan, which focuses on improving treatment options for adolescent alcohol misuse by optimizing ways to combine medications with behavioral interventions, dovetails the mentoring goals by providing a vehicle for mentoring junior scientists in: i) mechanisms of alcohol use disorder (AUD) pathogenesis and treatment effects, ii) clinical trial methods, iii) ecological momentary assessment (EMA) and psychophysiological research approaches, and iv) training in the responsible conduct of research. The candidate’s goal is to further develop and refine an experimental therapeutics approach (R01 AA007850) that yields high quality information to inform decisions about whether further development of novel treatments is warranted. This work centers on developing innovative human laboratory paradigms and related methods that reliably predict the efficacy of novel pharmacological and behavioral interventions in the real world and inform models of AUD etiology. This K24 will support the collection of pilot data for an integrative neurobehavioral therapy that combines a promising novel medication, shown to reduce alcohol use and craving in adults, with a gold standard psychosocial intervention for treating AUD among adolescents. Adolescence is a critical period for the pathogenesis of alcohol use disorder (AUD). Alcohol use typically begins during adolescence and prevalence rates for AUD peak before age 21. Yet, despite clinical demand, AUD treatments for youth rely on psychosocial interventions that yield only modest benefits. One potential way to improve adolescent alcohol treatment is to augment the best available psychosocial interventions with pharmacotherapy. Although the FDA approved four medications to help treat AUD in adults, no medication is indicated for adolescent use and controlled clinical trials with teenagers are almost nonexistent. Optimizing treatment options for youth will require closing this important gap in medication development research.

项目摘要/摘要这项K24中级研究和心理计划旨在为候选人提供受保护的时间直接患者护理对青春期酒精滥用和精神的研究（POR）进行研究（POR）成瘾科学转化研究的初级临床研究者。了解行为如何在受控实验室环境中测量的生理和神经认知测定可以利用提前了解药物如何影响现实世界中的酒精使用需要临床专业知识和行为神经科学，心理生理学和临床试验方法。近二十年来，候选人已经建立了一个富有成效且持续资助的POR计划，该计划将理论驱动的假设转化为对现实世界应用的临床前和人类实验室研究。拟议的综合计划将促进候选人在POR中的心理初级临床研究者的能力，并增强他作为独立的临床科学家。研究计划的重点是改善治疗方案青少年酒精滥用，通过优化将药物与行为干预，搭配的方法相结合的方法通过为精神上的初级科学家提供心理目标：i）酒精使用机制疾病（AUD）发病机理和治疗效果，ii）临床试验方法，iii）生态瞬间评估（EMA）和心理生理研究方法以及IV）培训负责任的行为研究。候选人的目标是进一步开发和完善实验疗法方法（R01 AA007850）产生高质量的信息，以告知有关是否进一步发展新颖的决策有必要进行治疗。这项工作集中于开发创新的人类实验室范式及相关的范例可靠地预测现实药理和行为干预效率的方法世界并告知AUD病因的模型。该K24将支持集成的试点数据的收集神经行为疗法结合了一种有希望的新型药物，显示出可减少酒精使用和渴望成人，并采用黄金标准的心理心理干预措施来治疗青少年的AUD。青少年是酒精使用障碍发病机理（AUD）的关键时期。通常使用酒精在青少年期间开始时，在21岁之前的AUD峰的患病率开始。然而，首选临床需求，青年的AUD治疗依赖于仅产生适度益处的社会心理干预措施。一种潜在的方式改善青少年酒精治疗方法是通过药物治疗。尽管FDA批准了四种帮助治疗成人AUD的药物，但没有药物是与青少年一起使用青少年使用和对照临床试验的指示几乎不存在。优化青年的治疗选择将需要缩小药物开发研究中的这一重要差距。