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
  Purpose

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.


Condition Intervention
Alcohol Drinking
Behavioral: Trier Social Stress Test

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Official Title: Validation in Humans of Genes Involved in Alcohol Drinking, Stress-Induced Alcohol Drinking and Relapse

Resource links provided by NLM:


Further study details as provided by Central Institute of Mental Health, Mannheim:

Enrollment: 281
Study Start Date: July 2005
Study Completion Date: March 2007
  Eligibility

Ages Eligible for Study:   18 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326742

Locations
Germany
Department of Addictive Behavior und Addiction Medicine, Central Institute of Mental Health
Mannheim, BW, Germany, 68159
Sponsors and Collaborators
Central Institute of Mental Health, Mannheim
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Karl F Mann, Prof Central Institute of Mental Health, Mannheim
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00326742     History of Changes
Other Study ID Numbers: NGFN 2 01 GS 0475
Study First Received: May 16, 2006
Last Updated: May 9, 2007
Health Authority: Germany: Ethics Commission

Keywords provided by Central Institute of Mental Health, Mannheim:
Alcoholism
Risk factors
Adolescence
Stress test
HPA system
Family adversity
Candidate genes
Cortisol
Adrenocorticotrophin

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior

ClinicalTrials.gov processed this record on July 24, 2014