Alcohol Addiction: A Systems-oriented Approach (eMedAlcohol)
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|ClinicalTrials.gov Identifier: NCT02910193|
Recruitment Status : Recruiting
First Posted : September 21, 2016
Last Update Posted : September 21, 2016
|Condition or disease|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||168 participants|
|Target Follow-Up Duration:||1 Day|
|Official Title:||Alcohol Addiction: A Systems-oriented Approach; Functional Validation II: Neuroimaging x Genetics|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Parents, children, siblings of alcohol-dependent patients
|healthy control subjects|
- Functional brain imaging assessed using a Siemens Magnetom TimTrio, 3 Tesla [ Time Frame: 3 year ]The primary outcome measure "Blood Oxygenation Level-Dependent (BOLD) response" will be assessed as a marker of neural activation via functional brain imaging (fMRI) during the processing of emotional, monetary and alcohol-associated cues as well as cognitive demand and at rest. A Siemens Magnetom TimTrio, 3 Tesla will be used.
- Structural brain imaging assessed using a Siemens Magnetom TimTrio, 3 Tesla [ Time Frame: 3 year ]The second primary outcome measure "brain tissue (Grey Matter, White Matter, Cerebrospinal fluid)" will be assessed and quantified via structural brain imaging using magnet resonance tomography as well as defusion-tensor imaging (MRI, DTI). A Siemens Magnetom TimTrio, 3 Tesla will be used.
- Assessment of genetic candidate markers and epigenetic markers of alcohol use disorders [ Time Frame: 3 years ]Secondary outcome measures will be genotype specification of candidate SNPs (e.g. BDNF, GATA4, OPRM1, D2/D1) derived from blood samples and according DNA/RNA array genotyping. Project aim is to conduct Genom-Wide Association Studies (GWAS) to investigate genetic factors that may predispose to or protect against alcohol use disorder. Further epigenetic methylation factors (i.e. homocysteine serum level) will be investigated to differentiate between healthy controls, alcohol-dependent patients and individuals at risk (first grade relatives).
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02910193
|Contact: Andreas Heinz, Prof., MD, PhDemail@example.com|
|Charite - Universitätsmedizin Berlin||Recruiting|
|Berlin, Germany, 10117|
|Contact: Andreas Heinz, Prof., MD, PhD 004930450517002 firstname.lastname@example.org|