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临床试验/NCT03818750
NCT03818750已完成不适用

Impact of Marketing of Alcohol Products on Young People

Rennes University Hospital2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2018年6月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
78
试验地点
2
主要终点
Changes in brain activation in areas involved in the control of reward and motivation when looking at neutral versus contextual ads

研究概览

简要总结

Impact of marketing of alcohol products on young people

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Experimental arm

Experimental

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

干预措施: MRI (Device)

Experimental arm

Experimental

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

干预措施: Alcohol Use Disorders Identification Test (Behavioral)

结局指标

主要结局

Changes in brain activation in areas involved in the control of reward and motivation when looking at neutral versus contextual ads

时间窗: 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)

次要结局

未报告次要终点

研究者

发起方
Rennes University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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