Alcohol AbuseDEPREV_Phase_2NCT05125783
Influence of Alcohol Marketing Stimuli in Adults With Regular Alcohol Consumption
An observational study of Alcohol Abuse, run by University Hospital, Brest at 7 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Abuse
- What is being tested?
- questionnaire
- How many people
- 287 participants
- Where
- 7 sitesFrance
- Study dates
- 7 Feb 2022to 7 Dec 2023
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients over 18 years of age followed in the addictology services participating in the study with moderate or severe alcohol use disorders.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Les Apsyades
Bouguenais, 44344
François-Néri VANDERMERSCH
Bouguenais
Morgane GUILLOU-LANDREAT
Brest, 29609
Jean-Pierre SIMSON
Brest
Pascale ROZEC
Landerneau
Benoit SCHRECK
Nantes
Hôpital Paul Brousse
Villejuif, 94804
About this study
Official title: 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.
- Conditions
- Alcohol Abuse
- Being tested
- questionnaire
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
Completion of the questionnaire by the patient after consultation with the practitioner.
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol marketing strategies
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.
Measured: 1 day
Secondary outcomes (6)
Alcohol craving
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? "
Measured: 1 day
Alcohol consumption
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?"
Measured: Day 1
Evaluation of severity of alcohol use disorders
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.
Measured: Day 1
Evaluation of severity of alcohol use disorders
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.
Measured: Day 1
Socio-demographic characteristics
The impact of marketing stimuli will be evaluated according to socio-demographic characteristics.
Measured: Day 1
Alcohol consumption
Assessment of the type of alcohol consumption
Measured: Day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start7 Feb 2022
- Primary completion7 Dec 2023
- Study completion7 Dec 2023
Why it stopped: Recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- Ecole des Hautes Etudes en Santé Publique
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125783
- Sponsor's protocol ID
- 29BRC21.0178
- Acronym
- DEPREV_Phase_2
- Status last verified
- Mar 2024
- First submitted
- 8 Nov 2021
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05125783
- Acronym / sponsor ID
- DEPREV_Phase_2 / 29BRC21.0178
- Conditions
- Alcohol Abuse
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties
- Enrolment
- 287 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- Ecole des Hautes Etudes en Santé Publique
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 7 Dec 2023 (actual)
- Study completion
- 7 Dec 2023 (actual)
- First posted
- 18 Nov 2021 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years of age followed in the addictology services participating in the study with moderate or severe alcohol use disorders.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| questionnaireCompletion of the questionnaire by the patient after consultation with the practitioner. | Other | – |
Primary outcome
Alcohol marketing strategies
Time frame: 1 day
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.
6 secondary outcomes
Alcohol craving
Time frame: 1 day
Alcohol consumption
Time frame: Day 1
Evaluation of severity of alcohol use disorders
Time frame: Day 1
Evaluation of severity of alcohol use disorders
Time frame: Day 1
Socio-demographic characteristics
Time frame: Day 1
Alcohol consumption
Time frame: Day1
Results and safety
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Abuse, run by University Hospital, Brest at 7 sites 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
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?
Alcohol marketing strategies (time frame: 1 day). 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 6 Feb 2025.