NCT03876132

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 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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

March 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 15, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

November 14, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2020

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

3 months

First QC Date

March 11, 2019

Last Update Submit

July 27, 2020

Conditions

Keywords

regular consumption of alcoholyoung adultsModerate or severe alcohol use disorders

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 day

Secondary Outcomes (5)

  • Level of anxiety

    1 day

  • Perceived risks

    1 day

  • Sensitivity to stimuli

    1 day

  • Attractiveness of stimuli

    1 day

  • Alcohol consumed

    1 day

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Patients aged 18 to 45 years with moderate or severe alcohol use disorders
  • Followed in addiction at Brest CHRU

You may not qualify if:

  • Major from 18 to 45 years
  • Current consumption of alcohol (multi-monthly)
  • Follow-up in primary care or addictology in Brest

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

AlcoholismLymphoma, Follicular

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

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

Study Record Dates

First Submitted

March 11, 2019

First Posted

March 15, 2019

Study Start

November 14, 2019

Primary Completion

February 25, 2020

Study Completion

February 25, 2020

Last Updated

July 29, 2020

Record last verified: 2020-07

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