- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02794311
Risk Factors Associated With Binge Drinking Behaviors Among College Students (AlcoolPredict)
June 10, 2020 updated by: CHU de Reims
AlcoholPredict: Neuropsychology, Brain Imaging and Genetic Polymorphisms in Binge Drinking
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.
Study Overview
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
125
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Reims, France, 51092
- CHU Reims
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Neuropsychological test : Mini International Neuropsychiatric Interview (M.I.N.I)
Time Frame: day 1
|
day 1
|
Neuropsychological test : Wisconsin Card Sorting Test (WCST)
Time Frame: V2(3 weeks later)
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V2(3 weeks later)
|
Genetics tests (Single Nucleotide Polymorphism)
Time Frame: V2(3 weeks later)
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V2(3 weeks later)
|
MRI - signal BOLD (" Blood Oxygen Level Dependant ").
Time Frame: V3(up to 2 month)
|
V3(up to 2 month)
|
Neuropsychological test : Family Informant Schedule and Criteria (FISC)
Time Frame: day 1
|
day 1
|
Neuropsychological test : Alcohol Use Questionnaire
Time Frame: day 1
|
day 1
|
Neuropsychological test :Trail Making Test, partie A et B
Time Frame: V3(up to 2 month)
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V3(up to 2 month)
|
Neuropsychological test : Plus/Minus Test
Time Frame: V3(up to 2 month)
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V3(up to 2 month)
|
Neuropsychological test :Go/No-Go
Time Frame: V3(up to 2 month)
|
V3(up to 2 month)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (Actual)
September 24, 2019
Study Completion (Actual)
September 24, 2019
Study Registration Dates
First Submitted
May 12, 2016
First Submitted That Met QC Criteria
June 3, 2016
First Posted (Estimate)
June 9, 2016
Study Record Updates
Last Update Posted (Actual)
June 12, 2020
Last Update Submitted That Met QC Criteria
June 10, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PO13129
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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