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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02794311
Other study ID # PO13129
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2015
Est. completion date September 24, 2019

Study information

Verified date June 2020
Source CHU de Reims
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to specify the psychological, cognitive, neuro-functional and genetic profile associated with binge drinker behaviors among young adults. Results will help identifying more precisely vulnerability factors associated with this pattern of alcohol consumption and guiding prevention efforts.


Description:

Binge drinking behavior is characterised by speed of drinking on a particular occasion, frequency of drunkenness during the most recent six month period, and the percentage of times getting drunk when drinking. The prevalence of weekly binge drinking among European Union drinkers in 2009 was reported to be 28% of the student population, and 33% among all young people aged 15-24. The consequences of this behavior are multiple and often dramatic, they include: academic failure, violent acts, rape, domestic or road accidents. The study aims to identify vulnerability factors associated with binge drinking. The protocol explores the psychological (personality), neuropsychological (executive functions, memory), genetic (snp polymorphisms) and neuro-anatomical (fMRI) patterns associated with binge drinking behavior.


Recruitment information / eligibility

Status Completed
Enrollment 125
Est. completion date September 24, 2019
Est. primary completion date September 24, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 25 Years
Eligibility Inclusion criteria :

- Males or females

- Right-handed

- Aged 18-25 years

- Native French speaker, able to read French and complete study evaluations

- Caucasian

- Able to provide informed written and verbal consent

Exclusion criteria

- A significant general medical illness, including neurological disorders, mental retardation or head trauma

- Depression, bipolar disorder, schizophrenia or schizoaffective disorder diagnostic according to DSM-IV

- Handling of psychotropics substances

- A sensorial impairment (visual and/or hearing)

- Women who are pregnant

- Contraindication to the use of MRI (pacemaker, metal in their body)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Alcoolpredict
psychological (personality), neuropsychological (executive functions, memory), genetic (snp polymorphisms) and neuro-anatomical (fMRI)

Locations

Country Name City State
France Chu Reims Reims

Sponsors (1)

Lead Sponsor Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neuropsychological test : Mini International Neuropsychiatric Interview (M.I.N.I) day 1
Primary Neuropsychological test : Wisconsin Card Sorting Test (WCST) V2(3 weeks later)
Primary Genetics tests (Single Nucleotide Polymorphism) V2(3 weeks later)
Primary MRI - signal BOLD (" Blood Oxygen Level Dependant "). V3(up to 2 month)
Primary Neuropsychological test : Family Informant Schedule and Criteria (FISC) day 1
Primary Neuropsychological test : Alcohol Use Questionnaire day 1
Primary Neuropsychological test :Trail Making Test, partie A et B V3(up to 2 month)
Primary Neuropsychological test : Plus/Minus Test V3(up to 2 month)
Primary Neuropsychological test :Go/No-Go V3(up to 2 month)
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