Learning in Young Adults as Predictor for the Development of Alcohol Use Disorders (LeAD)
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ClinicalTrials.gov Identifier: NCT01744834 |
Recruitment Status
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Active, not recruiting
First Posted
: December 7, 2012
Last Update Posted
: August 10, 2017
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Tracking Information | |||||||||||||
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First Submitted Date | December 6, 2012 | ||||||||||||
First Posted Date | December 7, 2012 | ||||||||||||
Last Update Posted Date | August 10, 2017 | ||||||||||||
Study Start Date | December 2012 | ||||||||||||
Actual Primary Completion Date | April 2015 (Final data collection date for primary outcome measure) | ||||||||||||
Current Primary Outcome Measures |
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
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Original Primary Outcome Measures | Same as current | ||||||||||||
Change History | Complete list of historical versions of study NCT01744834 on ClinicalTrials.gov Archive Site | ||||||||||||
Current Secondary Outcome Measures |
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
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Original Secondary Outcome Measures | Same as current | ||||||||||||
Current Other Outcome Measures | Not Provided | ||||||||||||
Original Other Outcome Measures | Not Provided | ||||||||||||
Descriptive Information | |||||||||||||
Brief Title | Learning in Young Adults as Predictor for the Development of Alcohol Use Disorders | ||||||||||||
Official Title | Learning in Young Adults as Predictor for the Development of Alcohol Use Disorders | ||||||||||||
Brief Summary | 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. |
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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. |
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Study Type | Observational | ||||||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||||||||
Biospecimen | Retention: Samples With DNA Description: Bloodsample are taken for genetic analysis |
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Sampling Method | Probability Sample | ||||||||||||
Study Population | random, representative sample from the respective city area (100 in Dresden, 100 in Berlin; male; born between January 1 1994 and November 30 1994 | ||||||||||||
Condition |
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Intervention | Not Provided | ||||||||||||
Study Groups/Cohorts | 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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Publications * | Not Provided | ||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status | Active, not recruiting | ||||||||||||
Actual Enrollment |
201 | ||||||||||||
Original Estimated Enrollment |
200 | ||||||||||||
Estimated Study Completion Date | March 2018 | ||||||||||||
Actual Primary Completion Date | April 2015 (Final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 18 Years (Adult) | ||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
Listed Location Countries | Germany | ||||||||||||
Removed Location Countries | |||||||||||||
Administrative Information | |||||||||||||
NCT Number | NCT01744834 | ||||||||||||
Other Study ID Numbers | HE2597/13-1;SM80/71;WI709/10-1 | ||||||||||||
Has Data Monitoring Committee | No | ||||||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||||||
IPD Sharing Statement | Not Provided | ||||||||||||
Responsible Party | Technische Universität Dresden | ||||||||||||
Study Sponsor | Technische Universität Dresden | ||||||||||||
Collaborators | Charite University, Berlin, Germany | ||||||||||||
Investigators |
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PRS Account | Technische Universität Dresden | ||||||||||||
Verification Date | August 2017 |