Randomized Diagnostic Trial Comparing Ethylglucuronide and Ethanol

NCT03276520 | Completed

• 1 other identifier: HCB/2015/0984
• Study Type: interventional
• Target: 162
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alcohol Use Disorder

Keywords

ethyl glucuronide, biomarker, diagnostic randomized trial

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

ethyl glucuronide

EXPERIMENTAL

subjects being screened with ethyl glucuronide

Diagnostic Test: ethyl glucuronide

ethanol

ACTIVE COMPARATOR

subjects being screened with ethanol

Diagnostic Test: ethanol

Interventions

ethyl glucuronide DIAGNOSTIC_TEST

alcohol urine screening with ethyl glucuronide

ethyl glucuronide

ethanol DIAGNOSTIC_TEST

alcohol urine screening with ethanol

ethanol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• conditions rendering patients unable to complete study procedures

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Addictive Behaviors Unit

Study Record Dates

• First Submitted: September 7, 2017
• First Posted: September 8, 2017
• Study Start: December 14, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 31, 2017
• Last Updated: September 11, 2017

Record last verified: 2017-09