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Completed

NCT Number: NCT00326742

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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Key information

Age range

18 year–19 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Mannheim, Baden-Wurttemberg, 68159, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trier Social Stress Test

Behavioral

Sponsors and collaborators

Lead sponsor

Central Institute of Mental Health, Mannheim

Other

Collaborators

  • German Federal Ministry of Education and Research

Registry information

Important dates

Study start
2005
Study completion
2007
First posted
May 17, 2006
Registry last updated
May 10, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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