<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03276520</url>
  </required_header>
  <id_info>
    <org_study_id>HCB/2015/0984</org_study_id>
    <nct_id>NCT03276520</nct_id>
  </id_info>
  <brief_title>Randomized Diagnostic Trial Comparing Ethylglucuronide and Ethanol</brief_title>
  <official_title>Filling the Gap Between Lab and Clinical Impact: an Open Randomized Diagnostic Trial Comparing Urinary Ethylglucuronide and Ethanol in Alcohol Dependent Outpatients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Clinic of Barcelona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Clinic of Barcelona</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Alcohol use disorders represent a major health burden. Efforts aiming at reducing&#xD;
      alcohol-related harm include early detection of those with risky drinking habits as well&#xD;
      detection of early relapse in patients with alcohol dependence who are detoxified and&#xD;
      committed to abstinence. Recently, ethyl glucuronide has been proved to be a good biomarker&#xD;
      for the detection of recent drinking. However, to date, no randomized diagnostic trial has&#xD;
      tested its impact on drinking outcomes. The aim of this study was to assess, with a&#xD;
      randomized design, the implications of ethyl glucuronide screening on alcohol outcomes,&#xD;
      compared to screening with a low-sensitivity biomarker such as ethanol.&#xD;
&#xD;
      Methods: alcohol dependent outpatients were randomized to either 24 weeks of continuous&#xD;
      screening with ethyl glucuronide or ethanol. Patients were aware of screening methods and&#xD;
      results. After 24 weeks, all participants were screened with ethyl glucuronide. Self-reports&#xD;
      were also gathered. A logistic regression model was performed comparing the rate of ethyl&#xD;
      glucuronide positive results at study end between groups. Generalized estimating equations&#xD;
      were performed to evaluate the descending rate of EtG positive patients in the EtG group,&#xD;
      measured month to month.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 14, 2016</start_date>
  <completion_date type="Actual">July 31, 2017</completion_date>
  <primary_completion_date type="Actual">July 1, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ethyl glucuronide positive rate</measure>
    <time_frame>after six months of ongoing urine screening</time_frame>
    <description>Percentage of patients screening positive to EtG at study end in each group</description>
  </primary_outcome>
  <primary_outcome>
    <measure>descending of Etg positive rates in the Etg group</measure>
    <time_frame>six months of ongoing urine screening</time_frame>
    <description>varying rate of EtG positive patinets in the intervention group during the study period</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">162</enrollment>
  <condition>Alcohol Use Disorder</condition>
  <arm_group>
    <arm_group_label>ethyl glucuronide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>subjects being screened with ethyl glucuronide</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ethanol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>subjects being screened with ethanol</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>ethyl glucuronide</intervention_name>
    <description>alcohol urine screening with ethyl glucuronide</description>
    <arm_group_label>ethyl glucuronide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>ethanol</intervention_name>
    <description>alcohol urine screening with ethanol</description>
    <arm_group_label>ethanol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  subjects had to be diagnosed of alcohol dependence according to DSM-IV, they had to&#xD;
             undergo regular urine screening as part of their treatment and be willing to give&#xD;
             informed written consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  conditions rendering patients unable to complete study procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>September 8, 2017</last_update_submitted>
  <last_update_submitted_qc>September 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Clinic of Barcelona</investigator_affiliation>
    <investigator_full_name>Antoni Gual</investigator_full_name>
    <investigator_title>Head of Addictive Behaviors Unit</investigator_title>
  </responsible_party>
  <keyword>ethyl glucuronide, biomarker, diagnostic randomized trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ethanol</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03276520
org study id: HCB/2015/0984
nct id: NCT03276520
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: ethyl glucuronide positive rate
time frame: after six months of ongoing urine screening
description: Percentage of patients screening positive to EtG at study end in each group
measure: descending of Etg positive rates in the Etg group
time frame: six months of ongoing urine screening
description: varying rate of EtG positive patinets in the intervention group during the study period
arm group label: ethyl glucuronide
arm group type: Experimental
description: subjects being screened with ethyl glucuronide
arm group label: ethanol
arm group type: Active Comparator
description: subjects being screened with ethanol
intervention type: Diagnostic Test
intervention name: ethyl glucuronide
description: alcohol urine screening with ethyl glucuronide
arm group label: ethyl glucuronide
intervention type: Diagnostic Test
intervention name: ethanol
description: alcohol urine screening with ethanol
arm group label: ethanol
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Hospital Clinic of Barcelona
investigator full name: Antoni Gual
investigator title: Head of Addictive Behaviors Unit
mesh term: Alcoholism
mesh term: Ethanol