Pregabalin Treatment of Alcohol Use Disorder.

普瑞巴林治疗酒精使用障碍。

• 批准号: 10203766
• 负责人: John J Mariani
• 金额: $ 19.24万
• 依托单位: NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-01 至 2023-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10203766
• 关键词: Acute; Alcohol consumption; Alcohol dependence; Alcohol withdrawal syndrome; Anxiety; Back; Behavior Therapy; Binding; Calcium; Calcium Channel; Clinical; Data; Development; Disulfiram; Dizziness; Dose; Double-Blind Method; Drowsiness; Drug Interactions; Drug Metabolic Detoxication; Enrollment; Health Care Costs; Heavy Drinking; Individual; Inpatients; Measures; Mediator of activation protein; Methods; Naltrexone; Outcome; Outcome Measure; Outpatients; Participant; Patients; Pattern; Pharmaceutical Preparations; Pharmacology; Pharmacotherapy; Pilot Projects; Placebos; Public Health; Randomized; Randomized Controlled Clinical Trials; Research; Research Project Grants; Safety; Sedation procedure; Serious Adverse Event; Sleep; Sleeplessness; Testing; Therapeutic; Time; TimeLine; Treatment outcome; United States; Withdrawal; Withdrawal Symptom; Woman; acamprosate; active method; alcohol abuse therapy; alcohol use disorder; clinical effect; comparative efficacy; craving; disorder later incidence prevention; drinking; drinking behavior; economic cost; efficacy evaluation; evidence base; gabapentin; improved; innovation; meetings; men; open label; pilot trial; pre-clinical; pregabalin; primary outcome; relapse risk; safety testing; side effect; symptom treatment; topiramate; voltage

Project Summary Despite substantial advances in the development of pharmacological and behavioral interventions, alcohol use disorder continues to be a significant public health problem in the United States, and significant gaps in the treatment armamentarium remain. Conceptually, the ideal pharmacotherapy for alcohol use disorder would be safe when administered to actively drinking patients, provide protection against mild-to- moderate alcohol withdrawal, and promote reductions in alcohol intake. No current pharmacotherapy for alcohol use disorder meets these criteria and thus represents an important unmet public health need. Pregabalin is a gabapentinoid with limited evidence of efficacy in treating the symptoms of alcohol withdrawal, as well as limited evidence of efficacy as a relapse prevention agent. A pilot study (n=15) conducted by our research group found pregabalin in doses up to 600 mg daily to be a safe, feasible, and generally well tolerated treatment for alcohol use disorder. The proposed study aims to build on these results and evaluate gabapentin as a potential antidipsotropic agent for alcohol use disorder. Pregabalin has proven to be a well- tolerated medication with a low abuse liability, thereby making it ideal for use in the outpatient setting. The proposed pilot project is to study the effects of pregabalin on the participants’ harmful drinking behavior in actively drinking outpatients with alcohol use disorder. Participants will be actively drinking alcohol at study entry, and the change in use pattern from baseline is measured throughout the study period. The specific aim is to determine if pregabalin treatment will significantly reduce harmful alcohol consumption as compared to placebo. The primary outcome measure will be the proportion of the heavy drinking days (defined as any day where the number of standard drinks was at least 5 for men and at least 4 for women) per week as measured by the timeline followback method. The proposed project is an 8-week randomized double-blind placebo- controlled pilot trial to evaluate the efficacy of pregabalin in the treatment of alcohol use disorder in 50 outpatients. All participants will receive weekly supportive behavioral treatment that promotes reductions in alcohol use, encourages 12-step meeting attendance, and facilitates compliance with study medication. The proposed research project would be the first study of pregabalin as a treatment for actively drinking outpatients, which would be of great clinical utility if proven to be effective.

项目摘要 尽管在药理学和行为干预的发展方面取得了实质性进展， 在美国，酒精使用障碍仍然是一个重大的公共健康问题，而且 治疗设施中的空白仍然存在。从概念上讲，酒精使用的理想药物疗法 如果对经常饮酒的患者进行治疗，这种紊乱是安全的，可以提供保护，防止轻微到 适度戒酒，促进减少酒精摄入量。没有目前的药物治疗 酒精使用障碍符合这些标准，因此代表着一个重要的未得到满足的公共卫生需求。 普瑞巴林是一种加巴喷丁类药物，在治疗酒精戒断症状方面的有效性证据有限， 以及作为复发预防药剂的有效性的有限证据。我们进行的一项初步研究(n=15) 研究小组发现，每天剂量高达600毫克的普瑞巴林是安全、可行的，总体上是好的 酒精使用障碍的耐受性治疗。拟议的研究旨在以这些结果为基础并评估 加巴喷丁作为一种潜在的酒精使用障碍的抗酒精剂。普瑞加巴林已经被证明是一口井- 耐受药物，滥用倾向低，因此非常适合在门诊环境中使用。这个 拟议的试点项目是研究普瑞巴林对参与者有害饮酒行为的影响 积极饮酒的门诊酒精使用障碍患者。参与者将在研究中积极饮酒 条目，并在整个研究期间衡量与基线相比使用模式的变化。具体目标 是为了确定普瑞巴林治疗是否会显著减少有害酒精的消耗 安慰剂。主要的结果衡量标准将是酗酒天数的比例(定义为任何一天 其中标准饮品的数量男性至少为5人，女性至少为4人) 通过时间线回溯方法。建议的项目是为期8周的随机双盲安慰剂- 普瑞巴林治疗酒精使用障碍50例的对照试验 门诊部。所有参与者每周都将接受支持性行为治疗，以促进减少 酒精使用，鼓励参加12步会议，并促进研究药物的依从性。这个 拟议的研究项目将是普瑞巴林作为积极饮酒治疗的第一个研究 门诊患者，如果被证明有效，将具有很大的临床实用价值。