Learning in Young Adults as Predictor for the Development of Alcohol Use Disorders (LeAD)
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|ClinicalTrials.gov Identifier: NCT01744834|
Recruitment Status : Active, not recruiting
First Posted : December 7, 2012
Last Update Posted : August 10, 2017
Overall goal of this study is to scrutinize the relation of learning behavior and related brain activity to the development of alcohol use disorder (AUD).
The researchers aim is to characterise a representative sample (200 men at age 18) with regard to learning parameters and their respective neural correlates which are thought to be indicators for the risk to develop an alcohol use disorder.
As part of a large multi-center study on alcohol dependency (in Dresden & Berlin, Germany) the researchers will characterize the sample and then prospectively assess alcohol consumption and development of AUDs over a period of three years.
Among other hypotheses it is expected that increased activation of striatal and prefrontal brain regions by the Pavlovian-to-instrumental transfer process is related to increased risk of developing an AUD.
|Condition or disease|
|High-risk Alcohol Consumption Pattern Low-risk Alcohol Consumption Pattern|
Hazardous alcohol use and alcohol use disorders (AUDs) are extremely prevalent in industrialized countries, affecting about 6 million individuals in Germany alone. The onset of most cases occurs during adolescence and early adulthood. Therefore, targeted prevention would be desirable especially in young people who are at high risk to develop AUDs. Since our knowledge about predisposing factors is limited, this project aims to identify mechanisms underlying liability for dysfunctional alcohol consumption (i.e. hazardous alcohol use, alcohol abuse and alcohol dependence). Based on the hypothesis that addiction is a disorder due to aberrant learning, the researchers expect that inter-individual differences in learning behavior should be associated with liability for as well as resiliency against AUD. To test the hypotheses, the researchers will characterize 200 men at age 18, and then prospectively assess alcohol consumption and development of AUDs over a period of three years. At baseline, the researchers will study three clusters of predictive variables: (i) individual learning parameters, estimated by computational modeling of behavioral performance in learning tasks such as Pavlovian-to-instrumental transfer, probabilistic reversal learning, and habitization-devaluation; (ii) individual neural correlates of learning, assessed by functional brain imaging during learning; and (iii) already established risk factors such as family history of alcoholism and impulsivity.
The specific aim is to test a set of related hypotheses. The researchers assume that high risk for AUD at baseline (cross-sectional design), increase of alcohol consumption after 3 years and incidence or progression of AUD during follow-up (prospective data) will be associated with decreased reward sensitivity, decreased punishment sensitivity, increased Pavlovian approach behavior ('sign tracking'), increased 'go' effect of conditioned appetitive stimuli, increased habitization, increased activation of striatal and prefrontal brain regions by the Pavlovian-to-instrumental transfer process, decreased correlation between striatal brain activity and prediction error during reversal learning.
|Study Type :||Observational|
|Actual Enrollment :||201 participants|
|Official Title:||Learning in Young Adults as Predictor for the Development of Alcohol Use Disorders|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||April 2015|
|Estimated Study Completion Date :||March 2018|
18-year-old males, representative random sample of the Dresden/Berlin (Germany) area, categorized as high and as low-risk drinkers respectively
- blood oxygenation level dependent (BOLD) response [ Time Frame: time point 1: when subject is 18 years of age ]investigation of neural activation of the mesolimbic system in a healthy random sample of male subjects categorized in high and low risk-for-AUD using 3 Tesla magnetic resonance imaging
- alcohol consumption pattern after and during a 3-year follow-up period [ Time Frame: assessment every 6 months ]time life follow-back assessment of alcohol consumption pattern will be assessed every 6 months, as well as standardized diagnostic interviewing for psychopathologies every 12 months
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): NCT01744834
|Technische Universität Dresden|
|Dresden, Saxony, Germany, 01187|
|Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden|
|Dresden, Saxony, Germany, 01307|
|Charité - Universitätsmedizin Berlin|
|Berlin, Germany, 10117|
|Principal Investigator:||Michael Smolka, Prof MD||Technische Universität Dresden, Dresden, Germany|
|Principal Investigator:||Andreas Heinz, Prof MD||Charité University, Berlin, Germany|
|Study Chair:||Andreas Heinz, Prof MD||Charité University, Berlin, Germany|
|Study Director:||Hans-Ulrich Wittchen, Prof PhD||Technische Universität Dresden, Dresden, Germany|