Randomized Diagnostic Trial Comparing Ethylglucuronide and Ethanol

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Alcohol Use Disorder

Intervention / Treatment
-----------------
* Diagnostic Test: ethyl glucuronide
* Diagnostic Test: ethanol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: conditions rendering patients unable to complete study procedures

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ethyl glucuronide<br>subjects being screened with ethyl glucuronide | Diagnostic Test: ethyl glucuronide<br>* alcohol urine screening with ethyl glucuronide<br>|
| Active Comparator: ethanol<br>subjects being screened with ethanol | Diagnostic Test: ethanol<br>* alcohol urine screening with ethanol<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ethyl glucuronide positive rate | Percentage of patients screening positive to EtG at study end in each group | after six months of ongoing urine screening | 
| descending of Etg positive rates in the Etg group | varying rate of EtG positive patinets in the intervention group during the study period | six months of ongoing urine screening | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ethyl glucuronide, biomarker, diagnostic randomized trial