Alcohol Addiction: A Systems-oriented Approach

NCT02910193 | Completed

• 1 other identifier: 01ZX1311E
• Study Type: observational
• Target: 159
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcoholism

Keywords

alcoholism; genetics; functional MRI; structural MRI; first-degree relatives

Outcome Measures

Primary Outcomes (2)

• Functional brain imaging assessed using a Siemens Magnetom TimTrio, 3 Tesla

  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.

  3 year

• Structural brain imaging assessed using a Siemens Magnetom TimTrio, 3 Tesla

  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.

  3 year

Secondary Outcomes (1)

• Assessment of genetic candidate markers and epigenetic markers of alcohol use disorders

  3 years

Study Arms (3)

alcohol-dependent patients

first-degree relatives

Parents, children, siblings of alcohol-dependent patients

healthy control subjects

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

primary care clinic and community sample

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Central Institute of Mental Health, Mannheim: collaborator

Study Sites (1)

Charite - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Related Publications (1)

• Spanagel R, Durstewitz D, Hansson A, Heinz A, Kiefer F, Kohr G, Matthaus F, Nothen MM, Noori HR, Obermayer K, Rietschel M, Schloss P, Scholz H, Schumann G, Smolka M, Sommer W, Vengeliene V, Walter H, Wurst W, Zimmermann US; Addiction GWAS Resource Group; Stringer S, Smits Y, Derks EM. A systems medicine research approach for studying alcohol addiction. Addict Biol. 2013 Nov;18(6):883-96. doi: 10.1111/adb.12109.

  PMID: 24283978 BACKGROUND

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

EDTA and PAX blood samples

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof., MD, PhD

Study Record Dates

• First Submitted: February 22, 2016
• First Posted: September 21, 2016
• Study Start: May 17, 2016
• Primary Completion: May 27, 2019
• Study Completion: May 27, 2019
• Last Updated: July 31, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)