Alcohol AbuseDEPREVNCT03876132
Perception of the Risks of Alcohol and Individual Vulnerabilities in Young Adults
An observational study of Alcohol Abuse, run by University Hospital, Brest at 1 site 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 to 45 years
- Conditions the study is for
- Alcohol Abuse
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 14 Nov 2019to 25 Feb 2020
- 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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients aged 18 to 45 years, followed in addictology or hospitalized in addictology at the Brest University Hospital with moderate or severe alcohol use disorders Major subjects (18-45 years) followed in primary care, meeting the inclusion criteria, with a selection according to level of disorder of alcohol use (absence, mild or moderate disorders). The interview will be integrated into the care in primary care.
Who may be able to join
- Patients aged 18 to 45 years with moderate or severe alcohol use disorders
- Followed in addiction at Brest CHRU
Who cannot join
- Major from 18 to 45 years
- Current consumption of alcohol (multi-monthly)
- Follow-up in primary care or addictology in Brest
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multifactorial Analysis of the Influence of Alcohol Marketing Stimuli Among Young Adults on the Perception of the Risks of Alcohol and According to the Types of Uses 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 focusing on the impact of alcohol marketing focus largely on young adolescents, and the links between exposure to marketing and the initiation of alcohol. But beyond these links, there has been little work on the impact of alcohol marketing in vulnerable subjects with regular alcohol consumption. Consumption of alcohol is one of the first causes of hospitalization in France (Paille and Reynaud, 2015), the damage is often restricted to notions of dependency risks, but they can appear as soon as consumptions of 1 US / d (Guerin and Laplanche, 2013) and they mainly concern 45-64 year olds. To our knowledge, there are no studies on the impact of alcohol marketing conducted on regular alcohol users, depending on how they use alcohol (use, or use disorders). mild, moderate or severe) in patients enrolled in primary care and specialized addiction care.
- Conditions
- Alcohol Abuse
- Keywords
- regular consumption of alcohol, young adults, Moderate or severe alcohol use disorders
- Medical subject headings
- Alcoholism, Lymphoma, Follicular
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol craving
Evaluation of alcohol craving, evaluated by a visual analogue scale from 0 to 100. It is in the form of a straight line of 100 mm. In one ends is indicated: absence of pain, to the other: unbearable pain. The patient places a marks between these two ends depending on the intensity of his pain at a given time. In practice, it is a small plastic strip provided, on a face of a cursor mobilized by the patient, on the other with millimeter graduations read by the caregiver.
Measured: 1 day
Secondary outcomes (5)
Level of anxiety
Assessment of the level of anxiety felt before and after the interview evaluated by a visual analogue scale from 0 to 100
Measured: 1 day
Perceived risks
Evaluation of perceived risks related to stimuli by individual interviews following the presentation of advertising images. It is not a scale but in interview where feelings are raised. No score.
Measured: 1 day
Sensitivity to stimuli
Assessment of sensitivity to stimuli presented
Measured: 1 day
Attractiveness of stimuli
Evaluation of the attractiveness of stimuli by individual interviews following the presentation of advertising images. It is not a scale but in interview where feelings are raised. No score.
Measured: 1 day
Alcohol consumed
Evaluation of the categories of alcohol consumed
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start14 Nov 2019
- Primary completion25 Feb 2020
- Study completion25 Feb 2020
Why it stopped: The number of patients is suffisant to answer to the primary outcome
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 23 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
- NCT03876132
- Sponsor's protocol ID
- 29BRC19.0059_DEPREV
- Acronym
- DEPREV
- Status last verified
- Jul 2020
- First submitted
- 11 Mar 2019
- Last updated
- 29 Jul 2020
- 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
Publications
Guillou-Landreat M, Dany A, Le Reste JY, Le Goff D, Benyamina A, Grall-Bronnec M, Gallopel-Morvan K. Impact of alcohol marketing on drinkers with Alcohol use disorders seeking treatment: a mixed-method study protocol. BMC Public Health. 2020 Apr 7;20(1):467. doi: 10.1186/s12889-020-08543-6.
PubMed 32264848
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multifactorial Analysis of the Influence of Alcohol Marketing Stimuli Among Young Adults on the Perception of the Risks of Alcohol and According to the Types of Uses and Individual Vulnerabilities
- ClinicalTrials.gov ID
- NCT03876132
- Acronym / sponsor ID
- DEPREV / 29BRC19.0059_DEPREV
- Conditions
- Alcohol Abuse
- Keywords
- regular consumption of alcohol, young adults, Moderate or severe alcohol use disorders
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The number of patients is suffisant to answer to the primary outcome
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- Ecole des Hautes Etudes en Santé Publique
- Study start
- 14 Nov 2019 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 15 Mar 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.
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 focusing on the impact of alcohol marketing focus largely on young adolescents, and the links between exposure to marketing and the initiation of alcohol. But beyond these links, there has been little work on the impact of alcohol marketing in vulnerable subjects with regular alcohol consumption. Consumption of alcohol is one of the first causes of hospitalization in France (Paille and Reynaud, 2015), the damage is often restricted to notions of dependency risks, but they can appear as soon as consumptions of 1 US / d (Guerin and Laplanche, 2013) and they mainly concern 45-64 year olds. To our knowledge, there are no studies on the impact of alcohol marketing conducted on regular alcohol users, depending on how they use alcohol (use, or use disorders). mild, moderate or severe) in patients enrolled in primary care and specialized addiction care.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients aged 18 to 45 years, followed in addictology or hospitalized in addictology at the Brest University Hospital with moderate or severe alcohol use disorders Major subjects (18-45 years) followed in primary care, meeting the inclusion criteria, with a selection according to level of disorder of alcohol use (absence, mild or moderate disorders). The interview will be integrated into the care in primary care.
Key inclusion criteria (2 listed)
- Patients aged 18 to 45 years with moderate or severe alcohol use disorders
- Followed in addiction at Brest CHRU
Key exclusion criteria (3 listed)
- Major from 18 to 45 years
- Current consumption of alcohol (multi-monthly)
- Follow-up in primary care or addictology in Brest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Alcohol craving
Time frame: 1 day
Evaluation of alcohol craving, evaluated by a visual analogue scale from 0 to 100. It is in the form of a straight line of 100 mm. In one ends is indicated: absence of pain, to the other: unbearable pain. The patient places a marks between these two ends depending on the intensity of his pain at a given time. In practice, it is a small plastic strip provided, on a face of a cursor mobilized by the patient, on the other with millimeter graduations read by the caregiver.
5 secondary outcomes
Level of anxiety
Time frame: 1 day
Perceived risks
Time frame: 1 day
Sensitivity to stimuli
Time frame: 1 day
Attractiveness of stimuli
Time frame: 1 day
Alcohol consumed
Time frame: 1 day
Results and safety
The study was stopped early (reason given: The number of patients is suffisant to answer to the primary outcome). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Derived from this study: PubMed 32264848Guillou-Landreat M, Dany A, Le Reste JY, Le Goff D, Benyamina A, Grall-Bronnec M, Gallopel-Morvan K. Impact of alcohol marketing on drinkers with Alcohol use disorders seeking treatment: a mixed-method study protocol. BMC Public Health. 2020 Apr 7;20(1):467. doi: 10.1186/s12889-020-08543-6.
- 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.
1 site 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 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 2 inclusion and 3 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 29 Jul 2020. 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 was stopped early (reason given: The number of patients is suffisant to answer to the primary outcome). 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 craving (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03876132, which also lists 1 linked publication.
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 29 Jul 2020.