High-risk Alcohol Consumption Pattern Clinical Trial
— LeADOfficial title:
Learning in Young Adults as Predictor for the Development of Alcohol Use Disorders
Verified date | March 2022 |
Source | Technische Universität Dresden |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 201 |
Est. completion date | December 2020 |
Est. primary completion date | April 2018 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 18 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Charité - Universitätsmedizin Berlin | Berlin | |
Germany | Technische Universität Dresden | Dresden | Saxony |
Germany | Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden | Dresden | Saxony |
Lead Sponsor | Collaborator |
---|---|
Technische Universität Dresden | Charite University, Berlin, Germany |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | blood oxygenation level dependent (BOLD) response | 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 | time point 1: when subject is 18 years of age | |
Secondary | alcohol consumption pattern after and during a 3-year follow-up period | 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 | assessment every 6 months |