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临床试验/NCT03276520
NCT03276520已完成不适用

Filling the Gap Between Lab and Clinical Impact: an Open Randomized Diagnostic Trial Comparing Urinary Ethylglucuronide and Ethanol in Alcohol Dependent Outpatients.

Hospital Clinic of Barcelona0 个研究点目标入组 162 人开始时间: 2016年12月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
162
主要终点
descending of Etg positive rates in the Etg group

研究概览

简要总结

Background: Alcohol use disorders represent a major health burden. Efforts aiming at reducing alcohol-related harm include early detection of those with risky drinking habits as well detection of early relapse in patients with alcohol dependence who are detoxified and committed to abstinence. Recently, ethyl glucuronide has been proved to be a good biomarker for the detection of recent drinking. However, to date, no randomized diagnostic trial has tested its impact on drinking outcomes. The aim of this study was to assess, with a randomized design, the implications of ethyl glucuronide screening on alcohol outcomes, compared to screening with a low-sensitivity biomarker such as ethanol.

Methods: alcohol dependent outpatients were randomized to either 24 weeks of continuous screening with ethyl glucuronide or ethanol. Patients were aware of screening methods and results. After 24 weeks, all participants were screened with ethyl glucuronide. Self-reports were also gathered. A logistic regression model was performed comparing the rate of ethyl glucuronide positive results at study end between groups. Generalized estimating equations were performed to evaluate the descending rate of EtG positive patients in the EtG group, measured month to month.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • subjects had to be diagnosed of alcohol dependence according to DSM-IV, they had to undergo regular urine screening as part of their treatment and be willing to give informed written consent.

排除标准

  • conditions rendering patients unable to complete study procedures

研究组 & 干预措施

ethyl glucuronide

Experimental

subjects being screened with ethyl glucuronide

干预措施: ethyl glucuronide (Diagnostic Test)

ethanol

Active Comparator

subjects being screened with ethanol

干预措施: ethanol (Diagnostic Test)

结局指标

主要结局

descending of Etg positive rates in the Etg group

时间窗: six months of ongoing urine screening

varying rate of EtG positive patinets in the intervention group during the study period

ethyl glucuronide positive rate

时间窗: after six months of ongoing urine screening

Percentage of patients screening positive to EtG at study end in each group

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Antoni Gual

Head of Addictive Behaviors Unit

Hospital Clinic of Barcelona

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