NCT03062189

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,704

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
Last Updated

February 27, 2017

Status Verified

January 1, 2017

Enrollment Period

5 months

First QC Date

December 14, 2016

Last Update Submit

February 24, 2017

Conditions

Binge Drinking

Outcome Measures

Primary Outcomes (1)

  • 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 (12)

  • Amount of alcoholic beverage consumed

    1 year

  • Type of alcoholic beverage consumed

    1 year

  • Frequency of alcohol consumption

    1 year

  • Alcohol consumption outside meals

    1 year

  • Frequency of alcohol drinking outside meals

    1 year

  • +7 more secondary outcomes

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

2,704 subjects attending high school in three italian cities

You may qualify if:

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

You may not qualify if:

  • Subjects that don't accept the interview

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Binge Drinking

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersAlcohol DrinkingDrinking BehaviorBehaviorMental Disorders

Study Officials

  • Giovanni Addolorato, MD

    Catholic University of Sacred Heart, Rome

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 14, 2016

First Posted

February 23, 2017

Study Start

January 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

February 27, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share