Effectiveness of Zonisamide in the Treatment of Alcohol Dependent Veterans

唑尼沙胺治疗酒精依赖退伍军人的有效性

• 批准号: 8819717
• 负责人: ALBERT JOSEPH ARIAS
• 金额: --
• 依托单位: VA CONNECTICUT HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-10-01 至 2020-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8819717
• 关键词: Adherence; Adverse effects; Afghanistan; Aftercare; Alcohol consumption; Alcohol dependence; Alcoholism; Anticonvulsants; Anxiety Disorders; Behavior Therapy; Biological Markers; Clinical; Consumption; Depressive disorder; Development; Diagnosis; Disease remission; Disulfiram; Dopamine; Dose; Double-Blind Method; Effectiveness; Functional disorder; Funding; General Population; Generic Drugs; Genes; Genetic Polymorphism; Genotype; Glutamates; Goals; Grant; Heavy Drinking; High Prevalence; Individual; Injection of therapeutic agent; Iraq; Measures; Medical; Medicine; Mental disorders; Methodology; Methods; Military Personnel; Mood Disorders; Naltrexone; Neurotransmitters; Outcome; Outcome Assessment; Outcome Measure; Patient-Focused Outcomes; Pharmaceutical Preparations; Pharmacogenetics; Pharmacologic Actions; Pharmacology; Pilot Projects; Placebo Control; Placebos; Population; Prevalence; Public Health; Randomized; Regimen; Resources; Sampling; Serotonin; Services; System; TimeLine; United States; United States Food and Drug Administration; Veterans; Vietnam; Work; acamprosate; alcohol craving; alcohol use disorder; alcoholism therapy; cost; craving; dosage; double-blind placebo controlled trial; drinking; effectiveness clinical trial; experience; follow-up; impression; improved outcome; innovation; men; personalized medicine; primary care setting; primary outcome; public health relevance; topiramate; translational neuroscience; treatment response; trial design

DESCRIPTION (provided by applicant): Title: Effectiveness of Zonisamide in the Treatment of Alcohol-Dependent Veterans ABSTRACT: Veterans have a high prevalence of alcohol dependence (AD), and those with AD also have a high rate of co-occurring psychiatric illnesses. Zonisamide is an extremely promising medicine for treating AD and managing other clinical problems including psychiatric disorders. Zonisamide is an affordable, generic anticonvulsant with unique actions on the major neurotransmitter systems involved in alcoholism, and it has neuroprotective effects. We recently completed a randomized, placebo- controlled pilot study of zonisamide in treating AD that showed significant reductions in heavy drinking, overall drinking, and alcohol craving. Zonisamide was very well tolerated in this study. In this application, we propose a larger (N = 160), 14-week, randomized, double-blind, placebo-controlled, effectiveness study of zonisamide in reducing heavy drinking and improving outcomes in a representative population of heavy-drinking veterans with AD. We describe zonisamide's potential to break through the barriers in the treatment of veterans with AD as well as its unique pharmacology that brings innovation to alcoholism treatment. An inexpensive, hypothesis-driven, exploratory, translational, pharmacogenetic component adds to the innovation and will work towards optimizing outcomes and personalizing treatment for veterans.

描述(由申请人提供)： 摘要：退伍军人有很高的酒精依赖(AD)发生率，AD患者也有很高的精神疾病共生率。唑尼沙胺是一种非常有前景的药物，用于治疗AD和处理其他临床问题，包括精神障碍。唑尼沙胺是一种价格低廉的非专利抗惊厥药物，对酒精中毒涉及的主要神经递质系统具有独特的作用，并具有神经保护作用。我们最近完成了一项佐尼沙胺治疗AD的随机、安慰剂对照的初步研究，结果显示大量饮酒、总体饮酒和饮酒欲望显著减少。在这项研究中，唑尼沙胺耐受性很好。在这项应用中，我们提出了一项更大规模(N=160)、为期14周的随机、双盲、安慰剂对照的唑尼沙胺在减少重度饮酒和改善AD退伍军人代表人群预后方面的有效性研究。我们描述了唑尼沙胺在治疗阿尔茨海默病退伍军人方面突破障碍的潜力，以及它带来酒精中毒治疗创新的独特药理。一种廉价的、假设驱动的、探索性的、转化性的、药物遗传学的成分增加了创新，并将致力于优化结果和退伍军人的个性化治疗。