- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05125783
Influence of Alcohol Marketing Stimuli in Adults With Regular Alcohol Consumption (DEPREV_Phase_2)
Multifactorial Analysis of the Influence of Alcohol Marketing Stimuli in Adults With Regular Alcohol Consumption on the Perception of Alcohol Risks and According to Types of Use and Individual Vulnerabilities
Alcohol use is the second leading cause of preventable death after smoking. The Evin law was built in 1991 with the goal of reducing exposure to alcohol marketing among the youngest. But this law is currently extremely weakened, and in a press release of February 26, 2018, the French Society of Alcoology is alarmed by these developments.
Studies on the impact of alcohol marketing focus for the most part on young adolescents and the links between marketing exposure and alcohol initiation. But beyond these links, little work has been done on the impact of alcohol marketing on vulnerable subjects with regular alcohol consumption. Alcohol consumption is one of the very first causes of hospitalization in France. The damage is often limited to the notion of risks of dependence, but it can appear as soon as consumption of 1 standard unit/day and mainly concerns the 45-64 year olds. To investigator knowledge, there are no studies on the impact of alcohol marketing carried out among regular alcohol users with moderate or severe alcohol use disorders.
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Bouguenais, France, 44344
- Les Apsyades
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Bouguenais, France
- François-Néri VANDERMERSCH
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Brest, France, 29609
- Morgane GUILLOU-LANDREAT
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Brest, France
- Jean-Pierre SIMSON
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Landerneau, France
- Pascale ROZEC
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Nantes, France
- Benoit SCHRECK
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Villejuif, France, 94804
- Hôpital Paul Brousse
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient over 18 years of age
- Patient with moderate to severe alcohol use disorders (beyond 3 out of 11 criteria on the DSM-5 scale)
- Non-opposition of the patient
Exclusion Criteria:
- Minor patient
- Patient who has already participated in phase 1 of the project
- Non-comprehension of the written French language
- Refusal to participate in the study
- Patient of legal age, deprived of liberty by a judicial or administrative decision or unable to express their consent
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Alcohol marketing strategies
Time Frame: 1 day
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Confirmation of alcohol marketing strategies significantly influencing alcohol risk perception alcohol cravings in patients with moderate to severe alcohol use disordersin a large population of people with alcohol use disorders seeking care.
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1 day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Alcohol craving
Time Frame: 1 day
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Self-assessment of craving measured by a visual analog scale from 0 (no craving for alcohol) to 10 (irrepressible craving for alcohol) relative to the question "How much do you estimate your craving for alcohol?
"
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1 day
|
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Alcohol consumption
Time Frame: Day 1
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Ability to control one's drinking, as measured by a visual analog scale from 0 (no ability to control) to 10 (perceived total control over drinking) relative to the question "How much do you estimate your ability to control your own drinking?"
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Day 1
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Evaluation of severity of alcohol use disorders
Time Frame: Day 1
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Severity of alcohol use disorders as measured by the number of DSM5 (Diagnostic and Statistical manual of Mental disorders 5) criteria.
The DSM5 score is diagnosis of addiction is based on welldefined criteria set out in the Diagnostic and Statistical manual of Mental disorders (DSM), the fifth edition of which was published in 2013.
The questionnaire consists of 11 items (diagnostic criteria for substance use disorders from the American Psychiatric Association's DSM V).
The presence of 2 to 3 criteria: low addiction / Presence of 4 to 5 criteria : moderate addiction / Presence of 6 or more criteria: severe addiction.
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Day 1
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Evaluation of severity of alcohol use disorders
Time Frame: Day 1
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Severity of alcohol use disorders as measured will be evaluated by Alcohol Use Disorders Identification Test (AUDIT) scale.
AUDIT is a 10-item screening tool to assess alcohol consumption, drinking behaviors, and alcohol-related problems.
A score of 8 or more is considered to indicate hazardous or harmful alcohol use.
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Day 1
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Socio-demographic characteristics
Time Frame: Day 1
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The impact of marketing stimuli will be evaluated according to socio-demographic characteristics.
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Day 1
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Alcohol consumption
Time Frame: Day1
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Assessment of the type of alcohol consumption
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Day1
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29BRC21.0178
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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