AlcoholismLeAD_P4NCT01858818
Project 4: Acute Effects of Alcohol on Learning and Habitization in Healthy Young Adults
An observational study of Alcoholism, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
This project aims to investigate how dysfunctional learning and habitization are affected by acute alcohol exposure, and whether individual differences in such alcohol effects can predict later development of Alcohol Use Disorders (AUDs). Read more about this study
- Who is it for?
- Ages 18 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alcoholism
- How many people
- 75 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2013to Oct 2014
- 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
- Healthy volunteers accepted
- Adult
Study population: random sampling of representative sample of 18 year old men in the area of Dresden
Who may be able to join
- men at age 18
- signed informed consent
- social drinking in the three months before participation participation, defined by at least two drinking days in any four weeks-interval
- ability to provide AUD information about 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)
- alcohol intake in the last 24 hours before test days
- use of medications or drugs 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
1 site in 1 country.
About this study
This project aims to investigate how dysfunctional learning and habitization are affected by acute alcohol exposure, and whether individual differences in such alcohol effects can predict later development of Alcohol Use Disorders (AUDs). Eighty 18-year-old healthy male subjects are tested on two days in a within-subjects design with blinded administration of alcohol vs. placebo and different behavioral and learning tasks. The investigators investigate how alcohol influences the performance during these tasks, whether alcohol effects differ between high- and low-risk subjects, and whether task performance under alcohol predicts future AUDs.
Read the detailed description
This project is part of a large multi-center study in Dresden and Berlin on Learning and Alcohol Dependence (LeAD). Project 4 aims to investigate how dysfunctional learning and habitization are affected by acute alcohol exposure, and whether individual differences in such alcohol effects can predict later development of AUDs. The project investigates eighty 18-year-old healthy male subjects, a subsample of LeAD project 1 that were already tested in Dresden using fMRI(Clinical Trials.govID: NCT01744834). Participants are tested on two days in a within-subjects design with blinded administration of alcohol or placebo. On 2 days participants are performing three behavioral and learning tasks measuring: 1. conditioning of money vs. drink stimuli 2. habitization vs. instrumental learning and 3. approach and avoidance behavior towards money and drink stimuli. The investigators investigate how alcohol influences the performance during these tasks, whether alcohol effects differ between high- and low-risk subjects, and whether task performance under alcohol predicts future AUDs. Participants will be followed up after three years. The project investigates whether single doses of alcohol affect the conditioning of monetary reward or alcoholic stimuli, impair instrumental learning, and enhance stimulus-response associations. The investigators want to test whether individual performance parameters are related to other risk factors for AUDs, e.g. family history of alcoholism or impulsivity.
- Conditions
- Alcoholism
- Keywords
- CAIS Computer Assisted Infusion System, real life drinking behavior, family history of alcoholism, conditioning, instrumental learning, habitization
- Medical subject headings
- Alcoholism
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 |
|---|---|---|
| healthy 18 year old males | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
individual learning parameters
estimated by computational modeling of behavioral performance in learning/conditioning tasks the investigators test effects of individual parameters on actual risk factors of AUDs and future AUDs
Measured: 2 days at age 18
Secondary outcomes (1)
individual approach/avoidance reaction time differences
individual reaction time (RT) differences between approach and avoidance of alcoholic, non-alcoholic, and monetary stimuli under alcohol vs. placebo are measured the investigators test effects of individual RT differences on actual risk factors of AUDs and future AUDs
Measured: 2 days at age 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startJun 2013
- Primary completionOct 2014
- Study completionOct 2014
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 AlcoholismStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulrich Zimmermann, PD Dr., Principal investigator, University Hospital Carl Gustav Carus at TU DresdenMichael Smolka, Prof. Dr., Principal investigator, Section of Systems Neuroscience at TU DresdenHans-Ulrich Wittchen, Prof. Dr., Study chair, TU DresdenAndreas Heinz, Prof. Dr., Study chair, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858818
- Sponsor's protocol ID
- ZI 1119/4-1
- Acronym
- LeAD_P4
- Status last verified
- Feb 2015
- First submitted
- 17 May 2013
- Last updated
- 12 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Junger E, Javadi AH, Wiers CE, Sommer C, Garbusow M, Bernhardt N, Kuitunen-Paul S, Smolka MN, Zimmermann US. Acute alcohol effects on explicit and implicit motivation to drink alcohol in socially drinking adolescents. J Psychopharmacol. 2017 Jul;31(7):893-905. doi: 10.1177/0269881117691454. Epub 2017 Feb 21.
PubMed 28675116
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project 4: Acute Effects of Alcohol on Learning and Habitization in Healthy Young Adults
- ClinicalTrials.gov ID
- NCT01858818
- Acronym / sponsor ID
- LeAD_P4 / ZI 1119/4-1
- Conditions
- Alcoholism
- Keywords
- CAIS Computer Assisted Infusion System, real life drinking behavior, family history of alcoholism, conditioning, instrumental learning, habitization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 21 May 2013 (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.
This project aims to investigate how dysfunctional learning and habitization are affected by acute alcohol exposure, and whether individual differences in such alcohol effects can predict later development of Alcohol Use Disorders (AUDs). Eighty 18-year-old healthy male subjects are tested on two days in a within-subjects design with blinded administration of alcohol vs. placebo and different behavioral and learning tasks. The investigators investigate how alcohol influences the performance during these tasks, whether alcohol effects differ between high- and low-risk subjects, and whether task performance under alcohol predicts future AUDs.
Detailed description
This project is part of a large multi-center study in Dresden and Berlin on Learning and Alcohol Dependence (LeAD). Project 4 aims to investigate how dysfunctional learning and habitization are affected by acute alcohol exposure, and whether individual differences in such alcohol effects can predict later development of AUDs. The project investigates eighty 18-year-old healthy male subjects, a subsample of LeAD project 1 that were already tested in Dresden using fMRI(Clinical Trials.govID: NCT01744834). Participants are tested on two days in a within-subjects design with blinded administration of alcohol or placebo. On 2 days participants are performing three behavioral and learning tasks measuring: 1. conditioning of money vs. drink stimuli 2. habitization vs. instrumental learning and 3. approach and avoidance behavior towards money and drink stimuli. The investigators investigate how alcohol influences the performance during these tasks, whether alcohol effects differ between high- and low-risk subjects, and whether task performance under alcohol predicts future AUDs. Participants will be followed up after three years. The project investigates whether single doses of alcohol affect the conditioning of monetary reward or alcoholic stimuli, impair instrumental learning, and enhance stimulus-response associations. The investigators want to test whether individual performance parameters are related to other risk factors for AUDs, e.g. family history of alcoholism or impulsivity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy 18 year old males | – | – |
Who may qualify
- Ages
- 18 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- random sampling of representative sample of 18 year old men in the area of Dresden
Key inclusion criteria (4 listed)
- men at age 18
- signed informed consent
- social drinking in the three months before participation participation, defined by at least two drinking days in any four weeks-interval
- ability to provide AUD information about 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
individual learning parameters
Time frame: 2 days at age 18
estimated by computational modeling of behavioral performance in learning/conditioning tasks the investigators test effects of individual parameters on actual risk factors of AUDs and future AUDs
1 secondary outcome
individual approach/avoidance reaction time differences
Time frame: 2 days at age 18
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 12 Feb 2015.
- Derived from this study: PubMed 28675116Junger E, Javadi AH, Wiers CE, Sommer C, Garbusow M, Bernhardt N, Kuitunen-Paul S, Smolka MN, Zimmermann US. Acute alcohol effects on explicit and implicit motivation to drink alcohol in socially drinking adolescents. J Psychopharmacol. 2017 Jul;31(7):893-905. doi: 10.1177/0269881117691454. Epub 2017 Feb 21.
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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.
Ulrich Zimmermann, PD Dr. principal investigator
University Hospital Carl Gustav Carus at TU Dresden
Michael Smolka, Prof. Dr. principal investigator
Section of Systems Neuroscience at TU Dresden
Hans-Ulrich Wittchen, Prof. Dr. study chair
TU Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcoholism, run by Technische Universität Dresden at 1 site 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 12 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
individual learning parameters (time frame: 2 days at age 18). 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 NCT01858818, 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 12 Feb 2015.