- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01744834
Learning in Young Adults as Predictor for the Development of Alcohol Use Disorders (LeAD)
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 plus additional follow-ups after that period, depending on future funding.
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.
Study Overview
Status
Detailed Description
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Berlin, Germany, 10117
- Charité - Universitätsmedizin Berlin
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Saxony
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Dresden, Saxony, Germany, 01307
- Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden
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Dresden, Saxony, Germany, 01187
- Technische Universitat Dresden
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- men at age 18
- ability to provide fully informed consent and to use self-rating scales
- habitual social drinking during the three months preceding participation, defined by at least two drinking days in any four weeks-interval
- being able to provide information concerning biological parents and grandparents
Exclusion Criteria:
- lifetime history of Diagnostic Statistical Manual-IV bipolar or psychotic disorder
- current diagnosis of one of the following disorders: major depressive disorder, generalized anxiety disorder, PTSD, borderline personality disorder, or obsessive-compulsive disorder
- prior treatment for any axis-I or axis-II disorder except for specific disorders of childhood and adolescence (i.e., oppositional defiant disorder, conduct disorder, ADHD)
- history of substance dependence other than nicotine dependence
- current substance use other than nicotine and alcohol as evinced by positive urine screen
- history of severe head trauma or other severe central neurological disorder (e.g. multiple sclerosis)
- any alcohol intake in the last 24 hours before test days
- use of medications or illicit substances known to interact with the central nervous system within the last 10 days or at least four half-lives post last intake
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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18-year-old males
18-year-old males, representative random sample of the Dresden/Berlin (Germany) area, categorized as high and as low-risk drinkers respectively
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
blood oxygenation level dependent (BOLD) response
Time Frame: time point 1: when subject is 18 years of age
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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
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time point 1: when subject is 18 years of age
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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alcohol consumption pattern after and during a 3-year follow-up period
Time Frame: assessment every 6 months
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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
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assessment every 6 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael Smolka, Prof MD, Technische Universität Dresden, Dresden, Germany
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HE2597/13-1;SM80/71;WI709/10-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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