Binge Drinking Among Youngs is a Risk Factor for Alcohol... | NCT03062189

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

NCT03062189

Sponsor

Catholic University of the Sacred Heart

Status

Completed

Last Update Posted

Feb 27, 2017Actual

Enrollment

2,704Actual

Phase

Not provided

Conditions

Binge Drinking

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Dec 14, 2016

First Submission Date that Met QC Criteria

Feb 20, 2017

First Posted Date

Feb 23, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2017

Last Update Posted Date

Feb 27, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Giovanni Addolorato, Principal Investigator, Catholic University of the Sacred HeartPrincipal Investigator

Lead Sponsor

Catholic University of the Sacred HeartOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,704Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Binge drinking behavior	Binge drinking behavior was defined as an alcohol consumption of more than 5 drinks within about two hour period	1 year

Secondary Outcomes

Measure	Description	Time Frame
Amount of alcoholic beverage consumed	One drink is defined as an amount of alcoholic beverages containing 12 g of absolute alcoho	1 year
Type of alcoholic beverage consumed		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

19 Years

Standard Ages

ChildAdult

Study Population

2,704 subjects attending high school in three italian cities

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Giovanni Addolorato, MD	Catholic University of Sacred Heart, Rome	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D063425	Binge Drinking

Ancestor Terms

ID	Term
D019973	Alcohol-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D000428	Alcohol Drinking

Browse Leaves

Not provided

Browse Branches

Not provided