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首页> 外文期刊>Trials >A proof-of-concept investigation into ketamine as a pharmacological treatment for alcohol dependence: study protocol for a randomised controlled trial
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A proof-of-concept investigation into ketamine as a pharmacological treatment for alcohol dependence: study protocol for a randomised controlled trial

机译：氯胺酮作为酒精依赖性药物治疗的概念验证研究：一项随机对照试验的研究方案

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Background Worldwide, alcohol abuse is a burgeoning problem. Abstinence is key to allow recovery of physical and mental health as well as quality of life, but treatment for alcohol dependence is associated with high relapse rates. Preliminary data have suggested that a combined repeated ketamine and psychological therapy programme may be effective in reducing relapse in severe alcohol use disorder. This non-commercial proof-of-concept trial is aimed at making a preliminary assessment of the effectiveness of this combined treatment in this patient group. Methods/design This is a phase II, randomised, double-blind, placebo-controlled, parallel-group clinical trial taking place in two sites in the UK: the South West of England and London. Ninety-six recently detoxified alcoholics, with comorbid depressive symptoms, will be randomised to one of four treatment arms. Patients will receive either three sessions of ketamine (0.8?mg/kg administered intravenously (IV) over 40?minutes) or placebo (50?ml saline 0.9% IV over 40?minutes) plus either seven sessions of manualised psychological therapy or an alcohol education control. Patients will be assessed at 3 and 6?months on a range of psychological and biological variables. The primary endpoints are (1) relapse rates at 6?months and (2) percentage days abstinent at 6?months. Secondary endpoints include 3 and 6?month percentage days abstinence, tolerability (indicated by dropout), adverse events, depressive symptoms, craving and quality of life. Discussion This study will provide important information on a new combined psychological and pharmacological intervention aimed at reducing relapse rates in alcoholics. The findings would have broad application given the worldwide prevalence of alcoholism and its associated medical, psychological and social problems. Trial registration ClinicalTrials.gov, NCT02649231 . Registered on 5 January 2016.
机译：背景技术在世界范围内，酗酒是一个新兴的问题。节制是恢复身心健康以及生活质量的关键，但是戒酒治疗与复发率高有关。初步数据表明，结合重复的氯胺酮和心理疗法可以有效减少严重饮酒障碍的复发。这项非商业性的概念验证试验旨在对该患者组中这种联合治疗的有效性进行初步评估。方法/设计这是一项II期，随机，双盲，安慰剂对照，平行组的临床试验，在英国的两个地点进行：英格兰西南部和伦敦。九十六名最近解毒的酗酒者，合并有抑郁症状，将被随机分配到四个治疗组之一。患者将接受三节氯胺酮（在40分钟内静脉内注射（IV）剂量为0.8？mg / kg）或安慰剂（在40分钟内的50μml生理盐水0.9％静脉内注射），外加七次手动心理治疗或饮酒教育控制。将在3个月和6个月时对患者进行一系列心理和生物学变量评估。主要终点是（1）6个月时的复发率和（2）6个月时戒断的天数。次要终点包括禁欲3个月和6个月百分比，耐受性（以辍学率表示），不良事件，抑郁症状，渴望和生活质量。讨论本研究将提供有关旨在降低酗酒者复发率的新的心理和药物联合干预措施的重要信息。鉴于酗酒及其相关的医学，心理和社会问题在世界范围内普遍存在，这些发现将得到广泛应用。试用注册ClinicalTrials.gov，NCT02649231。 2016年1月5日注册。

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