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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Catholic University of the Sacred Heart

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 14, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings