AlcoholismIMAJNCT03818750
Impact of Marketing of Alcohol Products on Young People
A study testing MRI and Alcohol Use Disorders Identification Test in people with Alcoholism, run by Rennes University Hospital at 1 site in France.
Trial summary
Impact of marketing of alcohol products on young people Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alcoholism
- What is being tested?
- MRI and Alcohol Use Disorders Identification Test
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jun 2018to 7 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- Cochlear implant
- Peripheral or neuronal stimulator
- Intra-ocular or brain metallic foreign bodies
- Any other contraindications to MRI
Trial locations and contacts
1 site in 1 country.
About this study
Impact of marketing of alcohol products on young people
Read the 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).
- Conditions
- Alcoholism
- Being tested
- MRI, Alcohol Use Disorders Identification Test
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
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.
Alcohol Use Disorders Identification TestBehavioural
Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: MRI; Behavioral: Alcohol Use Disorders Identification Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start13 Jun 2018
- Primary completion7 Mar 2019
- Study completion7 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ecole des Hautes Etudes en Santé Publique
- Responsible party
- Sponsor
- Investigators
- Romain Moirand, MD, PhD, Principal investigator, CHU of Rennes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818750
- Sponsor's protocol ID
- 35RC18_8845_IMAJ
- Other IDs
- 2018-A00219-46
- Acronym
- IMAJ
- Status last verified
- Mar 2019
- First submitted
- 5 Sep 2018
- Last updated
- 11 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Marketing of Alcohol Products on Young People
- ClinicalTrials.gov ID
- NCT03818750
- Acronym / sponsor ID
- IMAJ / 35RC18_8845_IMAJ
- Conditions
- Alcoholism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- Ecole des Hautes Etudes en Santé Publique
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- 7 Mar 2019 (actual)
- Study completion
- 7 Mar 2019 (actual)
- First posted
- 28 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Device: MRI, Behavioral: Alcohol Use Disorders Identification TestPatients (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 |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
- Cardiac pacemaker or implanted defibrillator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRISubjects 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. | Device | Experimental arm |
| Alcohol Use Disorders Identification TestQuestionnaire | Behavioural | Experimental arm |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Romain Moirand, MD, PhD principal investigator
CHU of Rennes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI and Alcohol Use Disorders Identification Test in people with Alcoholism, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2019.