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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05125783
Other study ID # 29BRC21.0178
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date February 7, 2022
Est. completion date December 7, 2023

Study information

Verified date March 2024
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Terminated
Enrollment 287
Est. completion date December 7, 2023
Est. primary completion date December 7, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
questionnaire
Completion of the questionnaire by the patient after consultation with the practitioner.

Locations

Country Name City State
France François-Néri VANDERMERSCH Bouguenais
France Les Apsyades Bouguenais
France Jean-Pierre SIMSON Brest
France Morgane GUILLOU-LANDREAT Brest
France Pascale ROZEC Landerneau
France Benoit SCHRECK Nantes
France Hôpital Paul Brousse Villejuif

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Brest Ecole des Hautes Etudes en Santé Publique

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 day
Secondary 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? " 1 day
Secondary 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?" Day 1
Secondary 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. Day 1
Secondary 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. Day 1
Secondary Socio-demographic characteristics The impact of marketing stimuli will be evaluated according to socio-demographic characteristics. Day 1
Secondary Alcohol consumption Assessment of the type of alcohol consumption Day1
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