Randomized Diagnostic Trial Comparing Ethylglucuronide and Ethanol

Alcohol Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03276520
• Other study ID #: HCB/2015/0984
• Status: Completed
• Phase: N/A
• First received: September 7, 2017
• Last updated: September 8, 2017
• Start date: December 14, 2016
• Est. completion date: July 31, 2017

Study information

• Verified date: September 2017
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: July 31, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Use Disorder

Intervention

Diagnostic Test:
• ethyl glucuronide
alcohol urine screening with ethyl glucuronide
• ethanol
alcohol urine screening with ethanol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ethyl glucuronide positive rate	Percentage of patients screening positive to EtG at study end in each group	after six months of ongoing urine screening
Primary	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