NCT00326742

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
281

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2006

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

May 10, 2007

Status Verified

May 1, 2007

First QC Date

May 16, 2006

Last Update Submit

May 9, 2007

Conditions

Alcohol Drinking

Keywords

AlcoholismRisk factorsAdolescenceStress testHPA systemFamily adversityCandidate genesCortisolAdrenocorticotrophin

Interventions

Trier Social Stress TestBEHAVIORAL

Eligibility Criteria

Age18 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Mannheim, Baden-Wurttemberg, 68159, Germany

Location

Related Publications (2)

  • 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. doi: 10.1038/sj.npp.1300395.

    PMID: 15100697BACKGROUND

  • 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. doi: 10.1111/j.1469-7610.1997.tb01602.x.

    PMID: 9363583BACKGROUND

Related Links

MeSH Terms

Conditions

Alcohol DrinkingAlcoholism

Interventions

Psychological Tests

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

  • Karl F Mann, Prof

    Central Institute of Mental Health, Mannheim

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 16, 2006

First Posted

May 17, 2006

Study Start

July 1, 2005

Study Completion

March 1, 2007

Last Updated

May 10, 2007

Record last verified: 2007-05

Locations

DE(1)