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首页> 外文期刊>Trials >A study protocol for the N-ICE trial: A randomised double-blind placebo-controlled study of the safety and efficacy of N-acetyl-cysteine (NAC) as a pharmacotherapy for methamphetamine (“ice”) dependence
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A study protocol for the N-ICE trial: A randomised double-blind placebo-controlled study of the safety and efficacy of N-acetyl-cysteine (NAC) as a pharmacotherapy for methamphetamine (“ice”) dependence

机译：N-ICE试验的研究方案：一种随机的双盲安慰剂对照研究N-乙酰半胱氨酸（NAC）作为甲基苯丙胺（“冰”）依赖的药物疗法的安全性和功效

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There are currently no approved pharmacotherapies for managing methamphetamine dependence. N-acetylcysteine (NAC) has been found to reduce the craving for methamphetamine and other drugs, but its effect on methamphetamine use and other clinically related endpoints are uncertain. The N-ICE trial is evaluating the safety and efficacy of NAC as a take-home pharmacotherapy for methamphetamine dependence. This is a two-arm parallel double-blind placebo-controlled three-site randomised trial (ratio 1:1) using permuted block randomisation, with variable block sizes. It is stratified by site, sex and whether the methamphetamine is injected or not. Participants (N?=?180; 60 per site) need to be dependent on methamphetamine, interested in reducing their methamphetamine use and not currently receiving treatment for substance use disorders. The trial is being conducted in outpatient settings in Melbourne, Geelong and Wollongong, Australia. Participants will receive either 2400?mg oral NAC or a matched placebo, delivered as a take-home medication for 12?weeks. Two 600?mg capsules are self-administered in the morning and two more in the evening. Adherence is being monitored using eCAP? medication bottle lids, which record the date and time of each occasion the bottle is opened. The primary outcome is methamphetamine use during the 12-week trial medication period, measured as (a) days of use, assessed using the timeline followback, and (b) methamphetamine-positive saliva tests, taken weekly. Secondary measures include weekly assessment of methamphetamine craving, severity of methamphetamine dependence, methamphetamine withdrawal symptoms and psychiatric symptoms (depression, suicidality, psychotic symptoms and hostility). Adverse events are monitored at each weekly assessment. Tolerability is assessed using the Treatment Satisfaction Questionnaire for Medication. The N-ICE trial is the first clinical trial to assess whether NAC can reduce methamphetamine use. This trial will improve our understanding of the potential utility of NAC in managing methamphetamine dependence and clinically related outcomes. If found to be effective, take-home NAC could be a potentially scalable and affordable pharmacotherapy option for treating methamphetamine dependence. Australian and New Zealand Clinical Trials Registry, ACTRN12618000366257 . Registered on 29 May 2018.
机译：目前没有批准的药剂治疗用于管理甲基苯丙胺依赖性。已发现N-乙酰半胱氨酸（NAC）减少对甲基苯丙胺和其他药物的渴望，但其对甲基苯丙胺使用的影响和其他临床相关终点是不确定的。 N-ICE试验正在评估NAC作为用于甲基苯丙胺依赖性的家用药物治疗的安全性和疗效。这是一个双臂并联双盲安慰剂控制的三个站点使用允许块随机化的双臂随机试验（比率1：1），具有可变块大小。它是由地点，性别和甲基苯丙胺是否注射的分层。参与者（N？= 180; 60个或每位）需要依赖于甲基甲基甲酸，对降低甲基苯丙胺使用而感兴趣，目前没有接受物质使用障碍的治疗。该试验在墨尔本，吉朗和威龙通，澳大利亚的门诊设施中进行。参与者将收到2400毫克口服NAC或匹配的安慰剂，作为11个星期的服用药物递送。两名600？镁胶囊在早上自我管理，晚上两次。使用ECAP监控遵守？药物瓶盖，记录每个场合的日期和时间打开瓶子。主要结果是在12周试验中使用的甲基苯丙胺使用，测量为（a）使用的日子，使用时间轴追随进行评估，并每周服用甲基苯丙胺阳性唾液测试。次要措施包括每周评估甲基苯丙胺渴望，甲基苯丙胺依赖性的严重程度，甲基苯丙胺戒断症状和精神症状（抑郁症，自杀，精神病症状和敌意）。在每周评估时监测不良事件。使用治疗满意度问卷进行药物评估耐受性。 N-ICE试验是第一次评估NAC是否可以降低甲基苯丙胺使用的临床试验。该试验将改善我们对NAC潜在效用的理解，以管理甲基苯丙胺依赖和临床相关的结果。如果发现有效，Tak-Home NAc可能是一种用于治疗甲基苯丙胺依赖性的潜在可扩展且价格合理的药物疗法。澳大利亚和新西兰临床试验登记处，ACTRN12618000366257 2018年5月29日注册。

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