- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03062189
Binge Drinking Among Youngs is a Risk Factor for Alcohol Use Disorders
February 24, 2017 updated by: Giovanni Addolorato, Catholic University of the Sacred Heart
Binge Drinking Among Young Students is a Risk Factor for the Development of Alcohol Use Disorders: Results From an Epidemiologic-observational Study
The purpose of this study was to assess drinking habits and patterns of alcohol consumption, smoking habits, use of illicit drugs and the prevalence of binge drinking and alcohol use disorders among Italian young students.
Furthermore to investigate the correlation between binge drinking and alcohol use disorders.
Study Overview
Status
Completed
Conditions
Detailed Description
This study was performed on 2,704 subjects attending high school, through the administration of questionnaires regarding socio-demographic data, anthropometric characteristics, pattern and amount of alcohol intake, smoking habits, use of illicit drugs and physical activity were administered to students.
Moreover mood and anxiety were evaluated through AUDIT, STAI-Y1, STAY-Y2 and ZUNG.
The aim of the study was to assess drinking habits and patterns of alcohol consumption, smoking habits, use of illicit drugs and the prevalence of binge drinking and alcohol use disorders among Italian young students.
Furthermore to investigate the correlation between binge drinking and alcohol use disorders.
Study Type
Observational
Enrollment (Actual)
2704
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
13 years to 19 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
2,704 subjects attending high school in three italian cities
Description
Inclusion Criteria:
- Subjects attending high school of three italian cities (Rome, Latina, Frosinone)
- Subjects aged between 13 and 19 years
- Subjects that accept the interview
Exclusion Criteria:
- Subjects that don't accept the interview
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Binge drinking behavior
Time Frame: 1 year
|
Binge drinking behavior was defined as an alcohol consumption of more than 5 drinks within about two hour period
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Amount of alcoholic beverage consumed
Time Frame: 1 year
|
One drink is defined as an amount of alcoholic beverages containing 12 g of absolute alcoho
|
1 year
|
|
Type of alcoholic beverage consumed
Time Frame: 1 year
|
1 year
|
|
|
Frequency of alcohol consumption
Time Frame: 1 year
|
1 year
|
|
|
Alcohol consumption outside meals
Time Frame: 1 year
|
One drink is defined as an amount of alcoholic beverages containing 12 g of absolute alcoho
|
1 year
|
|
Frequency of alcohol drinking outside meals
Time Frame: 1 year
|
One drink is defined as an amount of alcoholic beverages containing 12 g of absolute alcoho
|
1 year
|
|
Amount of cigarettes smoked
Time Frame: 1 year
|
1 year
|
|
|
Frequency of cigarettes smoked
Time Frame: 1 year
|
1 year
|
|
|
Type of illicit drugs used
Time Frame: 1 year
|
1 year
|
|
|
Frequency of illicit drugs used
Time Frame: 1 year
|
1 year
|
|
|
Diagnosis of Alcohol Use Disorder
Time Frame: 1 year
|
According AUDIT score
|
1 year
|
|
STAI score
Time Frame: 1 year
|
STAI assess existing anxiety a predisposition to anxious reaction as a personality characteristic.
Itis structuredby two axes (y1 for state anxiety and y2 for trait anxiety), both consisting of 20 multiple-choice items; each item has a score from 1 to 4; the total score of y1 and y 2 axes can range from 20 to 80.
This test was selected for simplicity, validity and reliability.
The subjects evaluated were divided as high and low anxious and a value of 40 was used to distinguish the two groups
|
1 year
|
|
Zung-SDS
Time Frame: 1 year
|
Zung-SDS constitutes an effective instrument in screening for depression and its positive predictive value of a diagnosis of depression is between 88.7% and 92.3%.
The Zung-SDS contains 20 multiple items with a score from 1 to 4 each; total score above 50 indicates a condition of depression
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Giovanni Addolorato, MD, Catholic University of Sacred Heart, Rome
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
January 1, 2015
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
December 14, 2016
First Submitted That Met QC Criteria
February 20, 2017
First Posted (Actual)
February 23, 2017
Study Record Updates
Last Update Posted (Actual)
February 27, 2017
Last Update Submitted That Met QC Criteria
February 24, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BingeDrinkingamongYoungStudy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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