Learning in Young Adults as Predictor for the Development of Alcohol Use Disorders (NCT01744834) | Clinical Trial Compass
CompletedNot Applicable
Learning in Young Adults as Predictor for the Development of Alcohol Use Disorders
Germany201 participantsStarted 2012-12
Plain-language 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 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.
Who can participate
Age range
18 Years – 18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
blood oxygenation level dependent (BOLD) response
Timeframe: time point 1: when subject is 18 years of age