High-risk Alcohol Consumption PatternLeADNCT01744834
Learning in Young Adults as Predictor for the Development of Alcohol Use Disorders
An observational study of High-risk Alcohol Consumption Pattern and Low-risk Alcohol Consumption Pattern, run by Technische Universität Dresden at 3 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 18 years, men only
- Conditions the study is for
- High-risk Alcohol Consumption Pattern, Low-risk Alcohol Consumption Pattern
- How many people
- 201 participants
- Where
- 3 sitesGermany
- Study dates
- Dec 2012to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 18 years
- Men only
- No healthy volunteers
- Adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Charité - Universitätsmedizin Berlin
Berlin, 10117
Technische Universität Dresden
Dresden, Saxony, 01187
Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden
Dresden, Saxony, 01307
About this study
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.
Read more
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.
Read the 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.
- Keywords
- Reward-based learning, Pavlovian-to-instrumental transfer, Functional imaging, alcohol use disorder risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: time point 1: when subject is 18 years of age
Secondary outcomes (1)
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
Measured: assessment every 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionApr 2018
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High-risk Alcohol Consumption PatternStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Responsible party
- Sponsor
- Investigators
- Michael Smolka, Prof MD, Principal investigator, Technische Universität Dresden, Dresden, GermanyAndreas Heinz, Prof MD, Principal investigator, Charité University, Berlin, GermanyAndreas Heinz, Prof MD, Study chair, Charité University, Berlin, GermanyHans-Ulrich Wittchen, Prof PhD, Study director, Technische Universität Dresden, Dresden, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01744834
- Sponsor's protocol ID
- HE2597/13-1;SM80/71;WI709/10-1
- Acronym
- LeAD
- Status last verified
- Mar 2022
- First submitted
- 6 Dec 2012
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Hentschel A, Petzold J, Chen H, Heinz A, Smolka MN. Higher alcohol use is associated with subsequent increased risk seeking toward gains: A longitudinal cohort study in young men. Alcohol Clin Exp Res (Hoboken). 2025 Jun;49(6):1306-1320. doi: 10.1111/acer.70051. Epub 2025 Apr 19.
PubMed 40252008
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning in Young Adults as Predictor for the Development of Alcohol Use Disorders
- ClinicalTrials.gov ID
- NCT01744834
- Acronym / sponsor ID
- LeAD / HE2597/13-1;SM80/71;WI709/10-1
- Keywords
- Reward-based learning, Pavlovian-to-instrumental transfer, Functional imaging, alcohol use disorder risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Study start
- Dec 2012
- Primary completion
- Apr 2018 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 7 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
alcohol consumption pattern after and during a 3-year follow-up period
Time frame: assessment every 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Derived from this study: PubMed 40252008Hentschel A, Petzold J, Chen H, Heinz A, Smolka MN. Higher alcohol use is associated with subsequent increased risk seeking toward gains: A longitudinal cohort study in young men. Alcohol Clin Exp Res (Hoboken). 2025 Jun;49(6):1306-1320. doi: 10.1111/acer.70051. Epub 2025 Apr 19.
- English study descriptionLink provided by the sponsor.
Related trials for High-risk Alcohol Consumption Pattern
Recruiting
Clinical Effectiveness of a Motivational Interviewing-Based Conversational Mobile Application for High-Risk Drinkers
Alcohol Drinking, High-Risk Drinking Patterns
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Smolka, Prof MD principal investigator
Technische Universität Dresden, Dresden, Germany
Andreas Heinz, Prof MD principal investigator
Charité University, Berlin, Germany
Andreas Heinz, Prof MD study chair
Charité University, Berlin, Germany
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High-risk Alcohol Consumption Pattern and Low-risk Alcohol Consumption Pattern, run by Technische Universität Dresden at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood oxygenation level dependent (BOLD) response (time frame: time point 1: when subject is 18 years of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01744834, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.