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

This study has been completed.
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by:
Central Institute of Mental Health, Mannheim
ClinicalTrials.gov Identifier:
NCT00326742
First received: May 16, 2006
Last updated: May 9, 2007
Last verified: May 2007

May 16, 2006
May 9, 2007
July 2005
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Complete list of historical versions of study NCT00326742 on ClinicalTrials.gov Archive Site
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Validation in Humans of Genes Involved in Alcohol Drinking, Stress-Induced Alcohol Drinking and Relapse
Validation in Humans of Genes Involved in Alcohol Drinking, Stress-Induced Alcohol Drinking and Relapse

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 drinking are recorded in a sample of healthy young adults who are genotyped for polymorphisms in candidate genes related to alcoholism. All participants undergo a standard laboratory psychosocial stress test. Our hypothesis is that specific genes can be identified which influence drinking by modulating stress response.

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Observational
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
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Alcohol Drinking
Behavioral: Trier Social Stress Test
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
281
March 2007
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Inclusion Criteria:

  • 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 Criteria:

  • 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
Both
18 Years to 19 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00326742
NGFN 2 01 GS 0475
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Central Institute of Mental Health, Mannheim
German Federal Ministry of Education and Research
Principal Investigator: Karl F Mann, Prof Central Institute of Mental Health, Mannheim
Central Institute of Mental Health, Mannheim
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP