Randomized Diagnostic Trial Comparing Ethylglucuronide and Ethanol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-14

Study Completion Date

2017-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Alcohol Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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ethyl glucuronide

subjects being screened with ethyl glucuronide

Group Type EXPERIMENTAL

ethyl glucuronide

Intervention Type DIAGNOSTIC_TEST

alcohol urine screening with ethyl glucuronide

ethanol

subjects being screened with ethanol

Group Type ACTIVE_COMPARATOR

ethanol

Intervention Type DIAGNOSTIC_TEST

alcohol urine screening with ethanol

Interventions

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ethyl glucuronide

alcohol urine screening with ethyl glucuronide

Intervention Type DIAGNOSTIC_TEST

ethanol

alcohol urine screening with ethanol

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.