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Binge Drinking And Addiction : Case-Control Study in Hospital (BACH)

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ClinicalTrials.gov Identifier: NCT03204214
Recruitment Status : Recruiting
First Posted : June 29, 2017
Last Update Posted : July 14, 2017
Sponsor:
Information provided by (Responsible Party):
Marie-Pierre TAVOLACCI, University Hospital, Rouen

Tracking Information
First Submitted Date June 28, 2017
First Posted Date June 29, 2017
Last Update Posted Date July 14, 2017
Actual Study Start Date April 1, 2016
Estimated Primary Completion Date July 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 28, 2017)
Frequent binge drinking [ Time Frame: 18-25 years old ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03204214 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Binge Drinking And Addiction : Case-Control Study in Hospital
Official Title Binge Drinking And Addiction : Case-Control Study in Hospital
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
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Cases recruited in Addiction Unit in Rouen University Hospital Controls recruited by the Clinical investigation center in Rouen University Hospital
Condition Alcohol Dependence
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 11, 2017)
252
Original Actual Enrollment
 (submitted: June 28, 2017)
256
Estimated Study Completion Date July 31, 2018
Estimated Primary Completion Date July 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria

  • 25 to 40 years:
  • alcohol addiction for the cases

Exclusion criteria

  • age <20 and >40
  • alcohol addiction for the controls
Sex/Gender
Sexes Eligible for Study: All
Ages 25 Years to 40 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Marie-Pierre TAVOLACCI, MD +3323288 ext 8862 MP.Tavolacci@chu-rouen.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03204214
Other Study ID Numbers 2016/166/OB
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Marie-Pierre TAVOLACCI, University Hospital, Rouen
Study Sponsor Marie-Pierre TAVOLACCI
Collaborators Not Provided
Investigators
Principal Investigator: Marie-Pierre TAVOLACCI, MD Rouen University Hospital
PRS Account University Hospital, Rouen
Verification Date July 2017