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

Alcohol Drinking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00326742
• Other study ID #: NGFN 2 01 GS 0475
• Status: Completed
• Phase: N/A
• First received: May 16, 2006
• Last updated: May 9, 2007
• Start date: July 2005
• Est. completion date: March 2007

Study information

• Verified date: May 2007
• Source: Central Institute of Mental Health, Mannheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 281
• Est. completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 19 Years

Eligibility

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

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Alcohol Drinking

Intervention

Behavioral:
• Trier Social Stress Test

Locations

Country	Name	City	State
Germany	Department of Addictive Behavior und Addiction Medicine, Central Institute of Mental Health	Mannheim	BW

Sponsors (2)

Lead Sponsor	Collaborator
Central Institute of Mental Health, Mannheim	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Laucht M, Esser G, Schmidt MH. Developmental outcome of infants born with biological and psychosocial risks. J Child Psychol Psychiatry. 1997 Oct;38(7):843-53. — View Citation

Zimmermann U, Spring K, Kunz-Ebrecht SR, Uhr M, Wittchen HU, Holsboer F. Effect of ethanol on hypothalamic-pituitary-adrenal system response to psychosocial stress in sons of alcohol-dependent fathers. Neuropsychopharmacology. 2004 Jun;29(6):1156-65. — View Citation

External Links

•   Homepage of the Department conducting the study