NCT05125783

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
287

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 18, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

February 7, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2023

Completed
Last Updated

February 6, 2025

Status Verified

March 1, 2024

Enrollment Period

1.8 years

First QC Date

November 8, 2021

Last Update Submit

February 4, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Alcohol craving

    1 day

  • Alcohol consumption

    Day 1

  • Evaluation of severity of alcohol use disorders

    Day 1

  • Evaluation of severity of alcohol use disorders

    Day 1

  • Socio-demographic characteristics

    Day 1

  • +1 more secondary outcomes

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients over 18 years of age followed in the addictology services participating in the study with moderate or severe alcohol use disorders.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Les Apsyades

Bouguenais, 44344, France

Location

François-Néri VANDERMERSCH

Bouguenais, France

Location

Morgane GUILLOU-LANDREAT

Brest, 29609, France

Location

Jean-Pierre SIMSON

Brest, France

Location

Pascale ROZEC

Landerneau, France

Location

Benoit SCHRECK

Nantes, France

Location

Hôpital Paul Brousse

Villejuif, 94804, France

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2021

First Posted

November 18, 2021

Study Start

February 7, 2022

Primary Completion

December 7, 2023

Study Completion

December 7, 2023

Last Updated

February 6, 2025

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication.

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available beginning five years and ending fifteen years following the final study report completion
Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

Locations