Filling the Gap Between Lab and Clinical Impact: an Open Randomized Diagnostic Trial Comparing Urinary Ethylglucuronide and Ethanol in Alcohol Dependent Outpatients.
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
- 否
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
subjects being screened with ethyl glucuronide
干预措施: ethyl glucuronide (Diagnostic Test)
ethanol
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
Antoni Gual
Head of Addictive Behaviors Unit
Hospital Clinic of Barcelona
