Status:

COMPLETED

Validation in Humans of Genes Involved in Alcohol Drinking, Stress-Induced Alcohol Drinking and Relapse

Lead Sponsor:

Central Institute of Mental Health, Mannheim

Collaborating Sponsors:

German Federal Ministry of Education and Research

Conditions:

Alcohol Drinking

Eligibility:

All Genders

18-19 years

Brief Summary

Aim of the project is to validate and functionally characterize the combined impact of candidate genes and stress exposure on drinking in adolescents. Lifetime and recent stress experiences and drinki...

Eligibility Criteria

Inclusion

  • All 18 or 19 year old participants of the Mannheim risk children study, i.e. a longitudinal birth cohort study that started in 1986 and had the inclusion criteria given below:
  • Male and female singletons, firstborn to their mothers between February 1st, 1986 and February 28th, 1988, consecutively recruited from 2 obstetric and 4 children's hospitals of the Rhine-Neckar region, Germany.
  • with no severe physical handicaps, obvious genetic defects, or metabolic diseases.
  • with German-speaking Caucasian parents.
  • Falling into one of 3 predefined groups with absent, moderate or high pre- and perinatal risk, operationalized by low gestational age at birth, low birth weight, and severity of the following: Preterm labor, EPH-gestosis, perinatal asphyxia, seizures, respiratory distress syndrome, perinatal sepsis.
  • Falling into one of 3 predefined groups with absent, moderate or high psychosocial risk, operationalized by a family risk index measuring the presence of 11 adverse family factors covering characteristics of the parents (e.g., psychiatric disorders), the partnership (e.g., disharmony), and the family environment (e.g., overcrowding)during a period of one year prior to birth.

Exclusion

  • Intelligence quotient or motor quotient below 70, or presence of severe neurological disorder such as infantile cerebral palsy, at age 15.
  • Women with known pregnancy.
  • Any physical of psychiatric disease requiring treatment
  • Incapable to give informed consent or to answer questionnaires in writing
  • Recent use of illegal drugs

Key Trial Info

Start Date :

July 1 2005

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 1 2007

Estimated Enrollment :

281 Patients enrolled

Trial Details

Trial ID

NCT00326742

Start Date

July 1 2005

End Date

March 1 2007

Last Update

May 10 2007

Active Locations (1)

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1

Department of Addictive Behavior und Addiction Medicine, Central Institute of Mental Health

Mannheim, Baden-Wurttemberg, Germany, 68159