<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/NCT03008928</url>
  </required_header>
  <id_info>
    <org_study_id>108/2016</org_study_id>
    <nct_id>NCT03008928</nct_id>
  </id_info>
  <brief_title>The Efficacy of the Alcooquizz App to Reduce Hazardous Alcohol Consumption</brief_title>
  <official_title>The Efficacy of the Alcooquizz App to Reduce Hazardous Alcohol Consumption: Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre for Addiction and Mental Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre for Addiction and Mental Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      New technologies offer potential ways to provide and deliver preventative interventions. With&#xD;
      respect to unhealthy alcohol use, offering people tools to assess and manage their risk at&#xD;
      any given time using their smartphone may represent an additional opportunity to disseminate&#xD;
      preventative interventions. Nevertheless, there is a lack of knowledge on the acceptability&#xD;
      and efficacy of smartphone applications for unhealthy alcohol use. Alcooquizz, a smartphone&#xD;
      app, has been previously evaluated using a before/after design without randomization, with&#xD;
      participants reporting reductions in drinking over time. The current trial proposes to&#xD;
      conduct an RCT, comparing reductions in alcohol consumption between participants provided&#xD;
      access to Alcooquizz to a no intervention control.&#xD;
&#xD;
      Participants will be recruited through Amazon's MTurk crowdsourcing platform. Potential&#xD;
      participants identified as problem drinkers based on an initial survey will be invited to&#xD;
      complete another survey in 6 months time. Those who agree to be followed-up will be&#xD;
      randomized to be provided a link to download the Alcooquizz app or to a no link control&#xD;
      condition. At six-months post-baseline, the MTurk portal will be used to send invitation&#xD;
      emails that contain a link to the follow-up survey that asks about their drinking and their&#xD;
      impressions of the app. The primary hypothesis to be tested is that participants receiving&#xD;
      access to the Alcooquizz app will report a greater level of reduction in number of drinks in&#xD;
      a typical week between the baseline survey and six-month follow-up as compared to&#xD;
      participants in the no information control condition.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">August 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>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in number of drinks in a typical week from baseline</measure>
    <time_frame>6 months</time_frame>
    <description>Sum of number of drinks consumed in a typical week</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">987</enrollment>
  <condition>Alcohol Consumption</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Alcooquizz app</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Alcooquizz is a smartphone app designed to promote reductions in alcohol consumption among people who drink in a hazarzdous fashion</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Alcooquizz</intervention_name>
    <arm_group_label>Alcooquizz app</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or over&#xD;
&#xD;
          -  A score of 8 or over on the Alcohol Use Disorders Identification Test (AUDIT)&#xD;
&#xD;
          -  Typically consumes 15 or more drinks per week,&#xD;
&#xD;
          -  Willingness to complete a 6-month follow-up survey&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John A Cunningham, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre for Addiction and Mental Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre for Addiction and Mental Health</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5S 2S1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>December 30, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>August 14, 2017</last_update_submitted>
  <last_update_submitted_qc>August 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre for Addiction and Mental Health</investigator_affiliation>
    <investigator_full_name>John Cunningham</investigator_full_name>
    <investigator_title>Senior Scientist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcohol Drinking</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03008928
org study id: 108/2016
nct id: NCT03008928
lead sponsor: 
has dmc: No
New technologies offer potential ways to provide and deliver preventative interventions. With
      respect to unhealthy alcohol use, offering people tools to assess and manage their risk at
      any given time using their smartphone may represent an additional opportunity to disseminate
      preventative interventions. Nevertheless, there is a lack of knowledge on the acceptability
      and efficacy of smartphone applications for unhealthy alcohol use. Alcooquizz, a smartphone
      app, has been previously evaluated using a before/after design without randomization, with
      participants reporting reductions in drinking over time. The current trial proposes to
      conduct an RCT, comparing reductions in alcohol consumption between participants provided
      access to Alcooquizz to a no intervention control.

      Participants will be recruited through Amazon's MTurk crowdsourcing platform. Potential
      participants identified as problem drinkers based on an initial survey will be invited to
      complete another survey in 6 months time. Those who agree to be followed-up will be
      randomized to be provided a link to download the Alcooquizz app or to a no link control
      condition. At six-months post-baseline, the MTurk portal will be used to send invitation
      emails that contain a link to the follow-up survey that asks about their drinking and their
      impressions of the app. The primary hypothesis to be tested is that participants receiving
      access to the Alcooquizz app will report a greater level of reduction in number of drinks in
      a typical week between the baseline survey and six-month follow-up as compared to
      participants in the no information control condition.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Change in number of drinks in a typical week from baseline
time frame: 6 months
description: Sum of number of drinks consumed in a typical week
arm group label: Control
arm group type: No Intervention
description: No intervention
arm group label: Alcooquizz app
arm group type: Experimental
description: Alcooquizz is a smartphone app designed to promote reductions in alcohol consumption among people who drink in a hazarzdous fashion
intervention type: Behavioral
intervention name: Alcooquizz
arm group label: Alcooquizz app
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John A Cunningham, PhD
role: Principal Investigator
affiliation: Centre for Addiction and Mental Health
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Centre for Addiction and Mental Health
investigator full name: John Cunningham
investigator title: Senior Scientist
mesh term: Alcohol Drinking
sharing ipd: No