NCT01503931

Brief Summary

The mesolimbic dopaminergic reward system is a key structure underlying addictive behaviour in alcohol addiction and is under control of prefrontal glutamatergic neurotransmission. The aim of the present multicenter-study in Berlin, Bonn and Mannheim is to use functional magnetic resonance imaging (fMRI) in alcohol addiction for endophenotyping in order to study the relevance of genetic variation, in particular in dopaminergic and glutamatergic genes, for addiction. The investigators will use a temporal discounting and a cue reactivity paradigm in alcoholics and healthy controls in order to 1) test the impact of genetic variation on activation of the mesolimbic system in these populations and to 2) to test their predictive effects for treatment outcome in alcoholics. The subproject will thus bridge animal research on genetically determined cue reactivity and human studies in alcoholics. Furthermore, the investigators will link these results to the measurement of glutamate and glutamine with magnetic resonance spectroscopy (MRS) in subproject SP14.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
480

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2008

Longer than P75 for all trials

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

June 1, 2008

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

4.7 years

First QC Date

January 2, 2012

Last Update Submit

January 27, 2016

Conditions

Keywords

alcohol dependence, functional magnetic resonance imaging, genetics, endophenotypes, dopamine,glutamate

Outcome Measures

Primary Outcomes (2)

  • blood oxygenation level dependent (BOLD) response

    investigation of neuronal activation of the mesolimbic system in alcohol-dependent patients and healthy controls using 3 tesla magnetic resonance imaging

    first assessment timepoint (alc.dep. patients: up to 21 days after detoxification)

  • Genetic endophenotypes

    study the relevance of genetic variation, in particular in dopaminergic and glutamatergic genes, for addiction

    second assessment timepoint: 3 days after first assessment time point

Secondary Outcomes (1)

  • Treatment response

    6 month follow up period beginning after second assessment timepoint

Study Arms (2)

Alcohol-dependent patients

* men and women, aged 18 to 75 * legally effective, written informed consent for participation within the study * right handedness * no other psychiatric disorder according to ICD 10 * no psychotropic substances within the last 7 days

Healthy control subjects

* men and women, aged 18 to 75 * legally effective, written informed consent for participation within the study * right handedness * no psychiatric disorder according to ICD 10 * no psychotropic substances within the last 7 days

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

primary care clinic

You may qualify if:

  • Healthy Controls
  • men and women, aged 18 to 75
  • legally effective, written informed consent for participation within the study
  • right handedness
  • no psychiatric disorder according to ICD 10
  • no psychotropic substances within the last 7 days Alcohol-dependent patients
  • men and women, aged 18 to 75
  • legally effective, written informed consent for participation within the study
  • right handedness
  • no other psychiatric disorder according to ICD 10
  • no psychotropic substances within the last 7 days

You may not qualify if:

  • physical disorders, which might interfere with the planned examination (e.g. cerebral or organic disorder)
  • MR-contraindication (z.B. pace maker, metalic or electronic implants, metal splinters, operation clips)
  • anamnestic manifest psychiatric axis I disorder and/or axis II according to ICD-10 except alcohol dependence for patients
  • medication or drug dependence
  • medication or drug abuse (randomized urin testing)
  • insufficient knowledge of German language
  • claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Psychiatry and Psychotherapy, Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

Location

Related Publications (1)

  • Jorde A, Bach P, Witt SH, Becker K, Reinhard I, Vollstadt-Klein S, Kirsch M, Hermann D, Charlet K, Beck A, Wimmer L, Frank J, Treutlein J, Spanagel R, Mann K, Walter H, Heinz A, Rietschel M, Kiefer F. Genetic variation in the atrial natriuretic peptide transcription factor GATA4 modulates amygdala responsiveness in alcohol dependence. Biol Psychiatry. 2014 May 15;75(10):790-7. doi: 10.1016/j.biopsych.2013.10.020. Epub 2013 Nov 4.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

whole blood (EDTA)

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Andreas Heinz, MD

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

January 2, 2012

First Posted

January 4, 2012

Study Start

June 1, 2008

Primary Completion

February 1, 2013

Study Completion

June 1, 2013

Last Updated

January 28, 2016

Record last verified: 2016-01

Locations