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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01692054
Other study ID # IIA5-2511DSM220
Secondary ID
Status Completed
Phase N/A
First received August 21, 2012
Last updated May 20, 2014
Start date June 2012
Est. completion date June 2013

Study information

Verified date May 2014
Source Technische Universität Dresden
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

The aim of the study is to improve the prognosis of the development of alcohol consumption by considering a variety of biological, psychological and social risk and protective factors. Therefore, young people who have been hospitalized due to acute alcohol intoxication within the past 5 to 12 years will be interviewed in order to assess aspects of healthy or impaired psychosocial development. The study will also include a control group of young adults who were in hospital due to other medical conditions. The identification of relevant cases will be based on medical records of several children's hospitals. These records will be analysed with regard to potential predictors of developmental hazards and protective factors.


Recruitment information / eligibility

Status Completed
Enrollment 394
Est. completion date June 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility experimental group:

Inclusion Criteria:

- male and female volunteers who were hospitalized due to acute alcohol intoxication from January 1, 2000 to December 31, 2006

- written informed consent by the subject

- minimum age of 20 years

Exclusion Criteria:

- incapability to conduct interview

control group:

Inclusion Criteria:

- male and female volunteers who were hospitalized due to other medical conditions but not acute alcohol intoxication from January 1, 2000 to December 31, 2006

- written informed consent by the subject

- minimum age of 20 years

Exclusion Criteria:

- incapability to conduct interview

Study Design

Observational Model: Case Control, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden Dresden Saxony

Sponsors (1)

Lead Sponsor Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Alcohol Use Disorders Alcohol Use Disorders as measured by the The Alcohol Use Disorders Identification Test 5 to 13 years No
Secondary Self-efficacy 5 to 13 years No
Secondary Life Satisfaction 5 to 13 years No
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