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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
Sponsor:
Collaborator:
Central Institute of Mental Health, Mannheim
Information provided by (Responsible Party):
Andreas Heinz, Charite University, Berlin, Germany

Brief Summary:
The goal of the multicenter subproject (SP) 10 of the eMED Alcohol Addiction Consortium - A Systems-Oriented Approach is to study neuroimaging x genetics predictions in an existing sample (NGFNplus) of tightly endophenotyped and genome-wide genotyped alcohol dependent subjects (N=240) and controls (N=240); (ii) to translate the results of neuroimaging and genetic analyses from an adolescent risk sample (IMAGEN) to adult disease (NGFNplus sample) by examining related MRI-paradigms tagging the same functional brain systems in both samples (e.g. reward system, inhibitory control system, emotion processing, working memory); (iii) to conduct a follow-up neuroimaging study on the NGFNplus sample validating the neurobehavioral risk profiles predictive for juvenile harmful alcohol use in adult patients with alcohol addiction, (iv) to expand the NGFNplus sample by including a new set of healthy subjects with high genetic risk (1st degree relatives of patients with alcohol addiction). The investigators will do so by using elaborate imaging genetic methods that are already available and successfully used in other multicenter studies by the investigator's research group (e.g. univariate analyses, functional and effective connectivity analyses, polygenetic scores, network topology) as well as by using complex computational algorithms and mathematical models, in particular advanced machine learning methods, developed in SP 6. The investigator's approach aims in the long to predict and characterize longitudinal outcomes in patients with alcohol addiction (5 years following our index session) and to complement the NGFN-sample with an add-on study with 1st degree relatives that will allow the investigators to test the generalizability of the identified predictive risk profiles for early risk identification.

Condition or disease
Alcoholism

Detailed Description:
The overall research goal of this project is (i) to study neuroimaging x genetics predictions in an existing sample (NGFNplus) of tightly endophenotyped and genome-wide genotyped alcohol dependent subjects (N=240) and controls (N=240); (ii) to translate the results of neuroimaging x genetic analyses from an adolescent risk sample (IMAGEN) to adult disease (NGFNplus sample) by examining related paradigms tagging the same functional systems in both samples; (iii) to conduct a follow-up neuroimaging study on the NGFNplus sample validating the neurobehavioral risk profiles predictive for harmful alcohol use in adolescents in adult patients with alcohol addiction (iv) to expand the NGFNplus sample by including a new set of healthy subjects with high genetic risk (1st degree relatives of patients with alcohol addiction). The investigators will do so by using imaging genetic methods that are already available and used in other multicenter studies by the investigator's research group (e.g. univariate analyses, functional and effective connectivity analyses, polygenetic scores, network topology) as well as by using computational algorithms and mathematical models, in particular advanced machine learning methods, developed in other sub projects (SPs) of the consortium in particular of SP4 and SP6. The investigator's approach will enable the researchers to characterize outcome longitudinal in patients with alcohol addiction (5 years following our index session) and to complement the NGFN-sample with an add-on study with 1st degree relatives that will allow the investigators to test the generalizability of the identified predictive risk profiles for early risk identification.

Study Type : Observational [Patient Registry]
Estimated Enrollment : 168 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine


Group/Cohort
alcohol-dependent patients
first-degree relatives
Parents, children, siblings of alcohol-dependent patients
healthy control subjects



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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
EDTA and PAX blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
primary care clinic and community sample
Criteria

Inclusion Criteria:

  • written informed consent
  • right handedness
  • no psychiatric disorders according to the International Classification of Diseases, Version 10 (ICD-10) (in patients: other than nicotine and alcohol dependence)
  • no use of psychotropic substances during previous 3 months

Exclusion Criteria:

  • severe illnesses (e.g. neurological diseases)
  • MR-contraindications (e.g. pacemaker, metal or electronic implants, metal splinters)
  • no psychiatric axis I-disorders according to the International Classification of Diseases, Version 10 (ICD-10) (in patients: other than nicotine and alcohol dependence)
  • no use of psychotropic substances during previous 3 months
  • insufficient language knowledge
  • claustrophobia
  • pregnancy in women

Information from the National Library of Medicine

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


Contacts
Contact: Andreas Heinz, Prof., MD, PhD 004930450517002 andreas.heinz@charite.de

Locations
Germany
Charite - Universitätsmedizin Berlin Recruiting
Berlin, Germany, 10117
Contact: Andreas Heinz, Prof., MD, PhD    004930450517002    andreas.heinz@charite.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
Central Institute of Mental Health, Mannheim

Additional Information:
Publications:
Responsible Party: Andreas Heinz, Prof., MD, PhD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02910193     History of Changes
Other Study ID Numbers: 01ZX1311E
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: September 21, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared within the study consortium "SysMedAlcoholism".

Keywords provided by Andreas Heinz, Charite University, Berlin, Germany:
alcoholism
genetics
functional MRI
structural MRI
first-degree relatives

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs