Impact of Marketing of Alcohol Products on Young People (IMAJ)
Primary Purpose
Alcoholism
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI
Alcohol Use Disorders Identification Test
Sponsored by
About this trial
This is an interventional other trial for Alcoholism
Eligibility Criteria
Inclusion Criteria:
- volunteer males
- aged 18-25
- right-handed
- persons that consume alcohol : " light drinkers " or "heavy drinkers" (defined with the AUDIT scale, scores between 1 to 7)
- written consent and agreement consent will be given
- Affiliated to the French social insurance
Exclusion Criteria:
- color-blind persons
- misuse of psychoactive products (except tobacco) (cannabis : no regular consumers -more than 10 times per month ; no users of other illicit drugs - even for occasional consumption)
- non fluent french speaking persons (people who couldn't understand instructions or asked questions)
- persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty
Related to the MRI:
- Cardiac pacemaker or implanted defibrillator
- Cochlear implant
- Peripheral or neuronal stimulator
- Intra-ocular or brain metallic foreign bodies
- Any other contraindications to MRI
Sites / Locations
- CHU de Rennes
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental arm
Arm 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
Outcomes
Primary Outcome Measures
Changes in brain activation in areas involved in the control of reward and motivation when looking at neutral versus contextual ads
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT03818750
First Posted
September 5, 2018
Last Updated
March 8, 2019
Sponsor
Rennes University Hospital
Collaborators
Ecole des Hautes Etudes en Santé Publique (EHESP)
1. Study Identification
Unique Protocol Identification Number
NCT03818750
Brief Title
Impact of Marketing of Alcohol Products on Young People
Acronym
IMAJ
Official Title
Impact of Marketing of Alcohol Products on Young People
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 13, 2018 (Actual)
Primary Completion Date
March 7, 2019 (Actual)
Study Completion Date
March 7, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
Collaborators
Ecole des Hautes Etudes en Santé Publique (EHESP)
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
Impact of marketing of alcohol products on young people
Detailed Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental arm
Arm Type
Experimental
Arm 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(s)
MRI
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Alcohol Use Disorders Identification Test
Intervention Description
Questionnaire
Primary Outcome Measure Information:
Title
Changes in brain activation in areas involved in the control of reward and motivation when looking at neutral versus contextual ads
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)
Time Frame
Month 1
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
volunteer males
aged 18-25
right-handed
persons that consume alcohol : " light drinkers " or "heavy drinkers" (defined with the AUDIT scale, scores between 1 to 7)
written consent and agreement consent will be given
Affiliated to the French social insurance
Exclusion Criteria:
color-blind persons
misuse of psychoactive products (except tobacco) (cannabis : no regular consumers -more than 10 times per month ; no users of other illicit drugs - even for occasional consumption)
non fluent french speaking persons (people who couldn't understand instructions or asked questions)
persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty
Related to the MRI:
Cardiac pacemaker or implanted defibrillator
Cochlear implant
Peripheral or neuronal stimulator
Intra-ocular or brain metallic foreign bodies
Any other contraindications to MRI
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Romain Moirand, MD, PhD
Organizational Affiliation
CHU of Rennes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Impact of Marketing of Alcohol Products on Young People
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