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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Charite University, Berlin, Germany
Information provided by (Responsible Party):
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT01744834
First received: December 6, 2012
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

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
High-risk Alcohol Consumption Pattern
Low-risk Alcohol Consumption Pattern

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Learning in Young Adults as Predictor for the Development of Alcohol Use Disorders

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • blood oxygenation level dependent (BOLD) response [ Time Frame: time point 1: when subject is 18 years of age ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • alcohol consumption pattern after and during a 3-year follow-up period [ Time Frame: assessment every 6 months ] [ Designated as safety issue: Yes ]
    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

Bloodsample are taken for genetic analysis


Estimated Enrollment: 200
Study Start Date: December 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 18 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744834

Locations
Germany
Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden
Dresden, Saxony, Germany, 01307
Technische Universität Dresden
Dresden, Saxony, Germany, 01187
Charité - Universitätsmedizin Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
Technische Universität Dresden
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
  More Information

Additional Information:
No publications provided

Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT01744834     History of Changes
Other Study ID Numbers: HE2597/13-1;SM80/71;WI709/10-1
Study First Received: December 6, 2012
Last Updated: March 20, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Technische Universität Dresden:
Reward-based learning
Pavlovian-to-instrumental transfer
Functional imaging
alcohol use disorder risk

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior

ClinicalTrials.gov processed this record on April 17, 2014