Randomized Diagnostic Trial Comparing Ethylglucuronide and Ethanol

September 8, 2017 updated by: Antoni Gual, Hospital Clinic of Barcelona

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

162

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ethyl glucuronide
subjects being screened with ethyl glucuronide
Diagnostic test: ethyl glucuronide
alcohol urine screening with ethyl glucuronide
Active Comparator: ethanol
subjects being screened with ethanol
Diagnostic test: ethanol
alcohol urine screening with ethanol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ethyl glucuronide positive rate
Time Frame: after six months of ongoing urine screening
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
Time Frame: six months of ongoing urine screening
varying rate of EtG positive patinets in the intervention group during the study period
six months of ongoing urine screening

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2016

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 31, 2017

Study Registration Dates

First Submitted

September 7, 2017

First Submitted That Met QC Criteria

September 7, 2017

First Posted (Actual)

September 8, 2017

Study Record Updates

Last Update Posted (Actual)

September 11, 2017

Last Update Submitted That Met QC Criteria

September 8, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCB/2015/0984

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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