N-乙酰半胱氨酸对酒精和可卡因使用障碍的影响：一项双盲随机对照试验。
2017年1月20日 更新者：Hospital de Clinicas de Porto Alegre
N-乙酰半胱氨酸 (NAC) 对酒精和可卡因使用障碍治疗的影响：一项双盲随机对照试验。
本研究评估了 N-乙酰半胱氨酸在治疗酒精和可卡因使用障碍中的用途。
饮酒者将分为两组，一组接受活性 N-乙酰半胱氨酸，另一组接受安慰剂。
同样的划分也会发生在可卡因使用者身上。
将评估 N-乙酰半胱氨酸在依从性、戒断、精神症状和应激生物标志物方面的影响。
研究概览
详细说明
N-乙酰半胱氨酸起到补充人体谷胱甘肽储存的作用。 谷胱甘肽是一种重要的抗氧化剂，还可调节 N-甲基-D-天冬氨酸 (NMDA) 谷氨酸能受体。 谷氨酸与物质使用障碍相关的神经适应有关，因此它被认为是针对这些障碍进行药理干预的潜在目标。 N-乙酰半胱氨酸还与星形胶质细胞上的胱氨酸-谷氨酸逆向转运蛋白相互作用，从而增加谷氨酸向细胞外空间的释放。
N-乙酰半胱氨酸的作用及其对成瘾障碍的影响最初是用动物模型研究的。 通过 N-乙酰半胱氨酸使谷氨酸水平正常化减少了小鼠的强迫性药物自我给药和寻药行为。 此外，对人类受试者也有可喜的结果，显示出对可卡因、酒精和大麻使用障碍的益处。
这项研究包括一项随机、双盲、安慰剂对照试验，有四组：酒精使用者分为 NAC 与安慰剂，可卡因使用者分为 NAC 与安慰剂。
研究类型
介入性
注册 (预期的)
100
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
RS
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Porto Alegre、RS、巴西、90420-020
- 招聘中
- Hospital de Clinicas de Porto Alegre - Unidade Alvaro Alvim
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接触：
- Thiago C Hartmann, MsC
- 电话号码：+55 51 3359 6476
- 邮箱：hartmann321@yahoo.com.br
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
男性
描述
纳入标准：
- 酒精或可卡因使用障碍的诊断
- 在成瘾治疗专业单位接受为期 7 天的住院治疗
排除标准：
- 另一种物质使用障碍（例外：烟草）
- 严重的医疗状况（心脏、肾脏或肝脏），妨碍受试者参与
- 哮喘或惊厥药物使用史
- 最近使用（
- 研究药物过敏反应史
- 自杀风险
- 无法理解知情同意书或无法遵守研究要求
- 任何严重的神经精神疾病，不是由物质使用引起的，需要特定的药物治疗，并且在研究者看来可能会干扰研究的发展（例如：痴呆，精神分裂症或其他精神病，多发性硬化症，严重抑郁症，中风，癫痫，躁郁症）
- 未能在研究第一周之前完成筛选程序
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：酒精 N-乙酰半胱氨酸
口服 600 毫克 N-乙酰半胱氨酸胶囊，每 12 小时一次，持续 8 周
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每天 1200 毫克 NAC，分两次服用，适用于有酒精使用障碍的受试者
其他名称：
|
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安慰剂比较：酒精安慰剂
与活性药物的颜色和气味相匹配的安慰剂胶囊
|
看起来与活性化合物完全相同的面粉丸，用于酒精使用障碍的受试者
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实验性的：可卡因 N-乙酰半胱氨酸
口服 600 毫克 N-乙酰半胱氨酸胶囊，每 12 小时一次，持续 8 周
|
对于患有可卡因使用障碍的受试者，每天服用 1200 毫克 NAC，分两次服用
其他名称：
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安慰剂比较：可卡因安慰剂
与活性药物的颜色和气味相匹配的安慰剂胶囊
|
看起来与活性化合物完全相同的面粉丸，用于患有可卡因使用障碍的受试者
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
参加所有研究预约的参与者人数
大体时间：8周
|
完成者（即
参加所有研究预约的受试者）与未完成者
|
8周
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
小便禁欲
大体时间：8周
|
可卡因吸毒者尿检阳性的数量
|
8周
|
|
通过呼气测醉器戒酒
大体时间：8周
|
酒精使用者的呼气分析呈阳性的数量
|
8周
|
|
自我报告的禁欲
大体时间：8周
|
时间线回溯法
|
8周
|
|
住院治疗天数
大体时间：长达 4 周
|
安慰剂组和干预组在住院治疗天数方面的差异（如果有的话）。
|
长达 4 周
|
|
CGI分数的变化
大体时间：8周
|
临床总体印象 (CGI) 分数的差异
|
8周
|
|
FAST 分数的变化
大体时间：8周
|
功能评估短期测试 (FAST) 的分数差异。
|
8周
|
|
抑郁症状
大体时间：8周
|
贝克抑郁量表 (BDI) 得分差异
|
8周
|
|
焦虑症状
大体时间：8周
|
贝克焦虑量表 (BAI) 分数的差异
|
8周
|
|
神经营养因子
大体时间：8周
|
关于脑源性神经营养因子 (BDNF) 剂量的组间差异
|
8周
|
|
GSSG
大体时间：8周
|
组间关于氧化型谷胱甘肽 (GSSG) 剂量的差异
|
8周
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谷胱甘肽
大体时间：8周
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关于谷胱甘肽 (GSH) 剂量的组间差异
|
8周
|
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GPx
大体时间：8周
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组间关于谷胱甘肽过氧化物酶 (GPx) 剂量的差异
|
8周
|
|
猫
大体时间：8周
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组间关于过氧化氢酶 (CAT) 剂量的差异
|
8周
|
|
TBARS
大体时间：8周
|
关于硫代巴比妥酸反应物质 (TBARS) 剂量的组间差异
|
8周
|
|
草皮
大体时间：8周
|
组间关于超氧化物歧化酶 (SOD) 剂量的差异
|
8周
|
|
羰
大体时间：8周
|
关于羰基剂量的组间差异
|
8周
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
不良事件
大体时间：8周
|
治疗紧急事件的系统评估 (SAFTEE) 应用程序
|
8周
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Lisia von Diemen, PhD、Federal University of Rio Grande do Sul (UFRGS)
- 首席研究员：Flavio Pechansky, PhD、Federal University of Rio Grande do Sul (UFRGS)
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2017年1月1日
初级完成 (预期的)
2018年7月1日
研究完成 (预期的)
2018年12月1日
研究注册日期
首次提交
2017年1月10日
首先提交符合 QC 标准的
2017年1月10日
首次发布 (估计)
2017年1月11日
研究记录更新
最后更新发布 (估计)
2017年1月24日
上次提交的符合 QC 标准的更新
2017年1月20日
最后验证
2017年1月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 150488
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
酒精 N-乙酰半胱氨酸的临床试验
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University of SevilleMaastricht University; Junta de Andalucia完全的
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Laval UniversityCanadian Institutes of Health Research (CIHR)招聘中
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Assistance Publique - Hôpitaux de ParisURC-CIC Paris Descartes Necker Cochin完全的
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Altor BioScience终止