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Binge DrinkingNCT03062189

Binge Drinking Among Youngs is a Risk Factor for Alcohol Use Disorders

An observational study of Binge Drinking, run by Catholic University of the Sacred Heart.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 13 to 19 yearsHealthy volunteers can take part
Conditions the study is for
Binge Drinking
How many people
2,704 participants
Where
No sites listed yet
Study dates
Jan 2015to Jun 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 19 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: 2,704 subjects attending high school in three italian cities

Who may be able to join

  • Subjects attending high school of three italian cities (Rome, Latina, Frosinone)
  • Subjects aged between 13 and 19 years
  • Subjects that accept the interview

Who cannot join

  • Subjects that don't accept the interview

About this study

Official title: 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.

Read the 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.

Conditions
Binge Drinking
Medical subject headings
Binge Drinking

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Binge drinking behavior

    Binge drinking behavior was defined as an alcohol consumption of more than 5 drinks within about two hour period

    Measured: 1 year

Secondary outcomes (12)

  1. Amount of alcoholic beverage consumed

    One drink is defined as an amount of alcoholic beverages containing 12 g of absolute alcoho

    Measured: 1 year

  2. Type of alcoholic beverage consumed

    Measured: 1 year

  3. Frequency of alcohol consumption

    Measured: 1 year

  4. Alcohol consumption outside meals

    One drink is defined as an amount of alcoholic beverages containing 12 g of absolute alcoho

    Measured: 1 year

  5. Frequency of alcohol drinking outside meals

    One drink is defined as an amount of alcoholic beverages containing 12 g of absolute alcoho

    Measured: 1 year

  6. Amount of cigarettes smoked

    Measured: 1 year

  7. Frequency of cigarettes smoked

    Measured: 1 year

  8. Type of illicit drugs used

    Measured: 1 year

  9. Frequency of illicit drugs used

    Measured: 1 year

  10. Diagnosis of Alcohol Use Disorder

    According AUDIT score

    Measured: 1 year

  11. STAI score

    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

    Measured: 1 year

  12. Zung-SDS

    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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2017
  2. Study startJan 2015
  3. Primary completionJun 2015
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,704 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03062189
Sponsor's protocol ID
BingeDrinkingamongYoungStudy
Status last verified
Jan 2017
First submitted
14 Dec 2016
Last updated
27 Feb 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Binge Drinking, run by Catholic University of the Sacred Heart.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Binge drinking behavior (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03062189.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2017.

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