This trial is active, not recruiting.

Conditions high-risk alcohol consumption pattern, low-risk alcohol consumption pattern
Sponsor Technische Universität Dresden
Collaborator Charite University, Berlin, Germany
Start date December 2012
End date April 2015
Trial size 201 participants
Trial identifier NCT01744834, HE2597/13-1;SM80/71;WI709/10-1


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
18-year-old males, representative random sample of the Dresden/Berlin (Germany) area, categorized as high and as low-risk drinkers respectively

Primary Outcomes

blood oxygenation level dependent (BOLD) response
time frame: time point 1: when subject is 18 years of age

Secondary Outcomes

alcohol consumption pattern after and during a 3-year follow-up period
time frame: assessment every 6 months

Eligibility Criteria

Male participants from 18 years up to 18 years old.

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

Additional Information

Official title Learning in Young Adults as Predictor for the Development of Alcohol Use Disorders
Principal investigator Michael Smolka, Prof MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Technische Universität Dresden.