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Perampanel Treatment of Alcohol Use Disorder

吡仑帕奈治疗酒精使用障碍

基本信息

批准号：
9789784
负责人：
ALBERT JOSEPH ARIAS
金额：
$ 18.44万
依托单位：
VIRGINIA COMMONWEALTH 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：
2018-09-25 至 2021-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9789784
关键词：
AMPA Receptors Adherence Alcohol consumption Alcohol dependence Alcoholic beverage heavy drinker Alcoholism Alcohols Animal Model Animals Anticonvulsants Anxiety Anxiety Disorders Attenuated Buprenorphine Cellular Phone Clinical Clinical Trials Clinical Trials Database Closure by clamp Cocaine Dependence Computer software Cross-Over Studies Data Disulfiram Dose Double-Blind Method Ethanol Euphoria FDA approved Glutamates Goals Human Infusion procedures Ingestion Institutional Review Boards Intravenous Laboratories Laboratory Study Literature Mammals Measurement Measures Monitor Moods Motivation Oral Outcome Measure Patient Self-Report Patients Pharmaceutical Preparations Pilot Projects Placebos Post-Traumatic Stress Disorders Procedures Property Public Health Questionnaires Randomized Reaction Relapse Research Research Personnel Rewards Safety Sampling Sedation procedure Testing Visual Work addiction alcohol abuse therapy alcohol craving alcohol effect alcohol response alcohol seeking behavior alcohol use disorder alcoholism therapy analog attenuation base capsule craving drinking effective therapy efficacy testing experimental study hedonic improved novel open label opioid use disorder pre-clinical research preclinical study primary outcome response

项目摘要

This project aims to meet the urgent need for developing better medications to treat alcohol use disorder (AUD), a major public health problem. The proposed study will test perampanel, a recently FDA approved anticonvulsant medication, to determine its clinical usefulness in treating alcoholism via an “alcohol challenge” paradigm paired with a small pilot clinical trial. Human alcohol challenge laboratory studies are an efficient and affordable way to screen medications for their usefulness in alcoholism treatment prior to performing a larger clinical trial. In this paradigm, subjects are given the medication perampanel (at either a high dose, low dose, or placebo dose, on subsequent challenge days), and then are administered intravenous ethanol to see if the medication reduces the rewarding and reinforcing effects of alcohol. The proposed study would be the first experiment in a line of research developing perampanel as a treatment for AUD. We will also conduct a very small open-label pilot study of the medication to explore efficacy and feasibility of perampanel treatment in a sample of subjects with AUD. Perampanel works primarily as a selective, non-competitive glutamatergic AMPA receptor antagonist, a property that makes it quite unique in the neuropharmacologic armamentarium. Preclinical research in animal models of alcoholism and other addictions suggests that AMPA receptor antagonists reduce drinking and relapse to addictive drugs. If perampanel proves to reduce the rewarding and reinforcing effects of alcohol in humans, and reduces drinking in the pilot study, it would provide a strong rationale for more definitive clinical trials with this medication.

该项目旨在满足开发更好的药物来治疗的迫切需求酒精使用障碍（AUD），一个重大的公共卫生问题。拟议的研究将测试吡仑帕奈是 FDA 最近批准的一种抗惊厥药物，以确定其通过“酒精挑战”范例配合治疗酒精中毒的临床实用性小型试点临床试验。人类酒精挑战实验室研究是一种高效且一种经济实惠的方法，可以在戒酒之前筛选药物在酗酒治疗中的作用进行更大规模的临床试验。在这个范例中，受试者被给予药物吡仑帕奈（高剂量、低剂量或安慰剂剂量，在随后的挑战中天），然后静脉注射乙醇，看看药物是否减少酒精的奖励和强化作用。拟议的研究将是第一个在开发吡仑帕奈作为 AUD 治疗方法的一系列研究中进行实验。我们将还对该药物进行了一项非常小型的开放标签试点研究，以探索疗效和吡仑帕奈治疗 AUD 受试者样本的可行性。吡仑帕奈作品主要作为选择性、非竞争性谷氨酸 AMPA 受体拮抗剂使其在神经药理学设备中非常独特的特性。对酗酒和其他成瘾动物模型的临床前研究表明 AMPA 受体拮抗剂可减少饮酒和药物成瘾的复发。如果吡仑帕奈被证明可以减少酒精对人类的奖赏和强化作用，并在试点研究中减少饮酒，这将为更多的研究提供强有力的理由这种药物的最终临床试验。