<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/NCT03818750</url>
  </required_header>
  <id_info>
    <org_study_id>35RC18_8845_IMAJ</org_study_id>
    <secondary_id>2018-A00219-46</secondary_id>
    <nct_id>NCT03818750</nct_id>
  </id_info>
  <brief_title>Impact of Marketing of Alcohol Products on Young People</brief_title>
  <acronym>IMAJ</acronym>
  <official_title>Impact of Marketing of Alcohol Products on Young People</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ecole des Hautes Etudes en Santé Publique (EHESP)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rennes University Hospital</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>
      Impact of marketing of alcohol products on young people&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Responsible for 3.3 million deaths worldwide, alcohol consumption causes diseases (liver&#xD;
      cirrhosis, cancers, etc.) and social problems (injuries, road accidents, alcohol dependence,&#xD;
      etc.). With one of the highest consumption rate in Europe, alcohol is the second cause of&#xD;
      avoidable mortality in France after tobacco (49.000 alcohol attributable deaths in 2009) and&#xD;
      its social cost is estimated to 120 billion euros. French teenage population is particularly&#xD;
      associated with heavy drinking patterns: in 2014, 49% of 17-year olds declared heavy episodic&#xD;
      drinking.&#xD;
&#xD;
      In that regard, several measures are recommended by health actors to combat this issue:&#xD;
      minimum unit pricing, sales ban to minor, low blood alcohol concentration for drivers, etc. A&#xD;
      specific measure concerns alcohol advertising restrictions. Some countries implemented&#xD;
      alcohol advertising regulation laws (Poland, Sweden, Finland, Estonia, etc.), including&#xD;
      France with the Evin law passed in 1991. This French law mandates advertising (and packaging)&#xD;
      content to strictly convey factual information and objective qualities of alcohol products&#xD;
      and thus bans attractive ads based on image and lifestyle evocations (seduction, power,&#xD;
      etc.).&#xD;
&#xD;
      The objective of this research is to investigate whether statutory framework for alcohol&#xD;
      advertising (e.g., Evin law) can effectively protect people against misleading, suggestive,&#xD;
      and appealing content. Little research has been conducted on this topic in spite of WHO's&#xD;
      recommendations (most research has explored the influence of exposure to ads but not the&#xD;
      impact of content).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 13, 2018</start_date>
  <completion_date type="Actual">March 7, 2019</completion_date>
  <primary_completion_date type="Actual">March 7, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in brain activation in areas involved in the control of reward and motivation when looking at neutral versus contextual ads</measure>
    <time_frame>Month 1</time_frame>
    <description>Significant change in cerebral activity (expressed as a significant variation in hemodynamic response BOLD) in the condition of alcohol ads with versus without context (party, sport, people) in areas involved in the control of reward and motivation (striatum dorsal, insula)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Alcoholism</condition>
  <arm_group>
    <arm_group_label>Experimental arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients (60) will be selected from the Alcohol Use Disorders Identification Test (AUDIT-C) :&#xD;
&quot;light drinkers&quot; (score between 1 to 3)&#xD;
&quot;heavy drinkers&quot; (score between 4 to 7) Two clinical visits will be realized in less than 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MRI</intervention_name>
    <description>Subjects review alcohol ads in different contexts (neutral context vs positive context such as parties and sport) and answer with buttons lever while being in the MRI to express their desire to consume alcohol or not.&#xD;
Subjects will be exposed to 288 ads set up.</description>
    <arm_group_label>Experimental arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Alcohol Use Disorders Identification Test</intervention_name>
    <description>Questionnaire</description>
    <arm_group_label>Experimental arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  volunteer males&#xD;
&#xD;
          -  aged 18-25&#xD;
&#xD;
          -  right-handed&#xD;
&#xD;
          -  persons that consume alcohol : &quot; light drinkers &quot; or &quot;heavy drinkers&quot; (defined with&#xD;
             the AUDIT scale, scores between 1 to 7)&#xD;
&#xD;
          -  written consent and agreement consent will be given&#xD;
&#xD;
          -  Affiliated to the French social insurance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  color-blind persons&#xD;
&#xD;
          -  misuse of psychoactive products (except tobacco) (cannabis : no regular consumers&#xD;
             -more than 10 times per month ; no users of other illicit drugs - even for occasional&#xD;
             consumption)&#xD;
&#xD;
          -  non fluent french speaking persons (people who couldn't understand instructions or&#xD;
             asked questions)&#xD;
&#xD;
          -  persons subject to major legal protection (safeguarding justice, guardianship,&#xD;
             trusteeship), persons deprived of liberty&#xD;
&#xD;
        Related to the MRI:&#xD;
&#xD;
          -  Cardiac pacemaker or implanted defibrillator&#xD;
&#xD;
          -  Cochlear implant&#xD;
&#xD;
          -  Peripheral or neuronal stimulator&#xD;
&#xD;
          -  Intra-ocular or brain metallic foreign bodies&#xD;
&#xD;
          -  Any other contraindications to MRI&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Romain Moirand, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU of Rennes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Rennes</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>September 5, 2018</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>March 8, 2019</last_update_submitted>
  <last_update_submitted_qc>March 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</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/NCT03818750
org study id: 35RC18_8845_IMAJ
secondary id: 2018-A00219-46
nct id: NCT03818750
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Impact of marketing of alcohol products on young people
Responsible for 3.3 million deaths worldwide, alcohol consumption causes diseases (liver
      cirrhosis, cancers, etc.) and social problems (injuries, road accidents, alcohol dependence,
      etc.). With one of the highest consumption rate in Europe, alcohol is the second cause of
      avoidable mortality in France after tobacco (49.000 alcohol attributable deaths in 2009) and
      its social cost is estimated to 120 billion euros. French teenage population is particularly
      associated with heavy drinking patterns: in 2014, 49% of 17-year olds declared heavy episodic
      drinking.

      In that regard, several measures are recommended by health actors to combat this issue:
      minimum unit pricing, sales ban to minor, low blood alcohol concentration for drivers, etc. A
      specific measure concerns alcohol advertising restrictions. Some countries implemented
      alcohol advertising regulation laws (Poland, Sweden, Finland, Estonia, etc.), including
      France with the Evin law passed in 1991. This French law mandates advertising (and packaging)
      content to strictly convey factual information and objective qualities of alcohol products
      and thus bans attractive ads based on image and lifestyle evocations (seduction, power,
      etc.).

      The objective of this research is to investigate whether statutory framework for alcohol
      advertising (e.g., Evin law) can effectively protect people against misleading, suggestive,
      and appealing content. Little research has been conducted on this topic in spite of WHO's
      recommendations (most research has explored the influence of exposure to ads but not the
      impact of content).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Changes in brain activation in areas involved in the control of reward and motivation when looking at neutral versus contextual ads
time frame: Month 1
description: Significant change in cerebral activity (expressed as a significant variation in hemodynamic response BOLD) in the condition of alcohol ads with versus without context (party, sport, people) in areas involved in the control of reward and motivation (striatum dorsal, insula)
arm group label: Experimental arm
arm group type: Experimental
description: Patients (60) will be selected from the Alcohol Use Disorders Identification Test (AUDIT-C) :
"light drinkers" (score between 1 to 3)
"heavy drinkers" (score between 4 to 7) Two clinical visits will be realized in less than 4 weeks
intervention type: Device
intervention name: MRI
description: Subjects review alcohol ads in different contexts (neutral context vs positive context such as parties and sport) and answer with buttons lever while being in the MRI to express their desire to consume alcohol or not.
Subjects will be exposed to 288 ads set up.
arm group label: Experimental arm
intervention type: Behavioral
intervention name: Alcohol Use Disorders Identification Test
description: Questionnaire
arm group label: Experimental arm
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Romain Moirand, MD, PhD
role: Principal Investigator
affiliation: CHU of Rennes
facility: 
country: France
responsible party type: Sponsor
mesh term: Alcoholism
sharing ipd: No