Randomized Diagnostic Trial Comparing Ethylglucuronide and Ethanol

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03276520

Enrollment

162

Registered

2017-09-08

Start date

2016-12-14

Completion date

2017-07-31

Last updated

2017-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder

Keywords

ethyl glucuronide, biomarker, diagnostic randomized trial

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.

Interventions

DIAGNOSTIC_TESTethyl glucuronide

alcohol urine screening with ethyl glucuronide

DIAGNOSTIC_TESTethanol

alcohol urine screening with ethanol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026