Impact of Marketing of Alcohol Products on Young People (IMAJ)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03818750|
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : January 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alcoholism||Device: MRI Behavioral: Alcohol Use Disorders Identification Test||Not Applicable|
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)|
|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|
Experimental: Experimental arm
Patients (60) will be selected from the Alcohol Use Disorders Identification Test (AUDIT-C) :
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
- 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)
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
|Contact: Karine GALLOPEL-MORVAN, PhD||+33 (0) 6 75 36 91 62||Karine.Gallopel-Morvan@ehesp.fr|
|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 firstname.lastname@example.org|
|Principal Investigator:||Romain Moirand, MD, PhD||CHU of Rennes|