- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00326742
Validation in Humans of Genes Involved in Alcohol Drinking, Stress-Induced Alcohol Drinking and Relapse
May 9, 2007 updated by: Central Institute of Mental Health, Mannheim
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
281
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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BW
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Mannheim, BW, Germany, 68159
- Department of Addictive Behavior und Addiction Medicine, Central Institute of Mental Health
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 19 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Karl F Mann, Prof, Central Institute of Mental Health, Mannheim
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2005
Study Completion (Actual)
March 1, 2007
Study Registration Dates
First Submitted
May 16, 2006
First Submitted That Met QC Criteria
May 16, 2006
First Posted (Estimate)
May 17, 2006
Study Record Updates
Last Update Posted (Estimate)
May 10, 2007
Last Update Submitted That Met QC Criteria
May 9, 2007
Last Verified
May 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NGFN 2 01 GS 0475
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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