Impact of Marketing of Alcohol Products on Young People
IMAJ
2 other identifiers
interventional
78
1 country
1
Brief Summary
Impact of marketing of alcohol products on young people
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 13, 2018
CompletedFirst Submitted
Initial submission to the registry
September 5, 2018
CompletedFirst Posted
Study publicly available on registry
January 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 7, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 7, 2019
CompletedMarch 11, 2019
March 1, 2019
9 months
September 5, 2018
March 8, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Month 1
Study Arms (1)
Experimental arm
EXPERIMENTALPatients (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
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Rennes
Rennes, 35033, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Romain Moirand, MD, PhD
CHU of Rennes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2018
First Posted
January 28, 2019
Study Start
June 13, 2018
Primary Completion
March 7, 2019
Study Completion
March 7, 2019
Last Updated
March 11, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share