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Impact of Marketing of Alcohol Products on Young People (IMAJ)

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ClinicalTrials.gov Identifier: NCT03818750
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : January 28, 2019
Sponsor:
Collaborator:
Ecole des Hautes Etudes en Santé Publique (EHESP)
Information provided by (Responsible Party):
Rennes University Hospital

Brief Summary:
Impact of marketing of alcohol products on young people

Condition or disease Intervention/treatment Phase
Alcoholism Device: MRI Behavioral: Alcohol Use Disorders Identification Test Not Applicable

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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Impact of Marketing of Alcohol Products on Young People
Actual Study Start Date : June 13, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental arm

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
Device: MRI

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.


Behavioral: Alcohol Use Disorders Identification Test
Questionnaire




Primary Outcome Measures :
  1. 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 ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03818750


Contacts
Contact: Karine GALLOPEL-MORVAN, PhD +33 (0) 6 75 36 91 62 Karine.Gallopel-Morvan@ehesp.fr

Locations
France
CHU de Rennes Recruiting
Rennes, France, 35033
Contact: Karine GALLOPEL-MORVAN, PhD    +33 (0) 6 75 36 91 62    Karine.Gallopel-Morvan@ehesp.fr   
Contact: Romain Moirand, MD, PhD    +33 (0) 2 99 28 65 31    romain.moirand@chu-rennes.fr   
Sponsors and Collaborators
Rennes University Hospital
Ecole des Hautes Etudes en Santé Publique (EHESP)
Investigators
Principal Investigator: Romain Moirand, MD, PhD CHU of Rennes

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03818750     History of Changes
Other Study ID Numbers: 35RC18_8845_IMAJ
2018-A00219-46 ( Other Identifier: ID-RCB )
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs