Binge Drinking And Addiction : Case-Control Study in Hosp... | NCT03204214

Studies
Binge Drinking And Addiction : Case-Control Study in Hospital

NCT03204214

Sponsor

Marie-Pierre TAVOLACCI

Status

Unknown status

Last Update Posted

Jul 14, 2017Actual

Enrollment

252Estimated

Phase

Not provided

Conditions

Alcohol Dependence

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2016Actual

Primary Completion Date

Jul 31, 2018Estimated

Completion Date

Jul 31, 2018Estimated

First Submitted Date

Jun 28, 2017

First Submission Date that Met QC Criteria

Jun 28, 2017

First Posted Date

Jun 29, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 11, 2017

Last Update Posted Date

Jul 14, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Case Control Study :

Objective:

Frequent Binge drinking during 18-25 years is a risk factor of alcohol addiction in adulthood (25-40 years) Hypothesis: 25% of frequent binge drinking, OR = 2, power 80%, alpha risk : 5% 126 Cases aged 25 to 40 years: alcohol addict patients recruited in Addiction Unit in Rouen University Hospital 126 controls aged 25 to 40 years: non alcohol addict recruited by the Clinical investigation center in Rouen University Hospital An anonymous self-questionnaire was completed Binge Drinking during 18-25 years was retrospectively evaluated Confusion biais was also recorded

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

252Estimated

Measure	Description	Time Frame
Frequent binge drinking		18-25 years old

Eligibility Module

Eligibility Criteria

Inclusion Criteria

25 to 40 years:
alcohol addiction for the cases

Exclusion criteria

age <20 and >40
alcohol addiction for the controls

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Cases recruited in Addiction Unit in Rouen University Hospital Controls recruited by the Clinical investigation center in Rouen University Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marie-Pierre TAVOLACCI, MD	Contact	+3323288	8862	MP.Tavolacci@chu-rouen.fr

Overall Officials

Name	Affiliation	Role
Marie-Pierre TAVOLACCI, MD	University Hospital, Rouen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rouen University Hospital	Recruiting	Rouen			France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31061035	Derived	Tavolacci MP, Berthon Q, Cerasuolo D, Dechelotte P, Ladner J, Baguet A. Does binge drinking between the age of 18 and 25 years predict alcohol dependence in adulthood? A retrospective case-control study in France. BMJ Open. 2019 May 5;9(5):e026375. doi: 10.1136/bmjopen-2018-026375.

ID	Term
D000437	Alcoholism
D063425	Binge Drinking

ID	Term
D019973	Alcohol-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders