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Randomized Diagnostic Trial Comparing Ethylglucuronide and Ethanol

Primary Purpose

Alcohol Use Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ethyl glucuronide
ethanol
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Alcohol Use Disorder focused on measuring ethyl glucuronide, biomarker, diagnostic randomized trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    ethyl glucuronide

    ethanol

    Arm Description

    subjects being screened with ethyl glucuronide

    subjects being screened with ethanol

    Outcomes

    Primary Outcome Measures

    ethyl glucuronide positive rate
    Percentage of patients screening positive to EtG at study end in each group
    descending of Etg positive rates in the Etg group
    varying rate of EtG positive patinets in the intervention group during the study period

    Secondary Outcome Measures

    Full Information

    First Posted
    September 7, 2017
    Last Updated
    September 8, 2017
    Sponsor
    Hospital Clinic of Barcelona
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03276520
    Brief Title
    Randomized Diagnostic Trial Comparing Ethylglucuronide and Ethanol
    Official Title
    Filling the Gap Between Lab and Clinical Impact: an Open Randomized Diagnostic Trial Comparing Urinary Ethylglucuronide and Ethanol in Alcohol Dependent Outpatients.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    December 14, 2016 (Actual)
    Primary Completion Date
    July 1, 2017 (Actual)
    Study Completion Date
    July 31, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Clinic of Barcelona

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Use Disorder
    Keywords
    ethyl glucuronide, biomarker, diagnostic randomized trial

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    162 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ethyl glucuronide
    Arm Type
    Experimental
    Arm Description
    subjects being screened with ethyl glucuronide
    Arm Title
    ethanol
    Arm Type
    Active Comparator
    Arm Description
    subjects being screened with ethanol
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    ethyl glucuronide
    Intervention Description
    alcohol urine screening with ethyl glucuronide
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    ethanol
    Intervention Description
    alcohol urine screening with ethanol
    Primary Outcome Measure Information:
    Title
    ethyl glucuronide positive rate
    Description
    Percentage of patients screening positive to EtG at study end in each group
    Time Frame
    after six months of ongoing urine screening
    Title
    descending of Etg positive rates in the Etg group
    Description
    varying rate of EtG positive patinets in the intervention group during the study period
    Time Frame
    six months of ongoing urine screening

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Randomized Diagnostic Trial Comparing Ethylglucuronide and Ethanol

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