Learning in Young Adults as Predictor for the Development of Alcohol Use Disorders (LeAD)

Tracking Information
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; (submitted: December 6, 2012)	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
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; (submitted: December 6, 2012)	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
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.
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	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA; Description: Bloodsample are taken for genetic analysis
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	High-risk Alcohol Consumption Pattern; Low-risk Alcohol Consumption Pattern
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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Active, not recruiting
Actual Enrollment; (submitted: April 23, 2015)	201
Original Estimated Enrollment; (submitted: December 6, 2012)	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: 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
Sex/Gender	Sexes Eligible for Study: Male
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	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
PRS Account	Technische Universität Dresden
Verification Date	August 2017