Project 4: Acute Effects of Alcohol on Learning and Habitization in Healthy Young Adults
LeAD_P4
1 other identifier
observational
75
1 country
1
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2013
CompletedFirst Posted
Study publicly available on registry
May 21, 2013
CompletedStudy Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedFebruary 12, 2015
February 1, 2015
1.3 years
May 17, 2013
February 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
2 days at age 18
Secondary Outcomes (1)
individual approach/avoidance reaction time differences
2 days at age 18
Other Outcomes (1)
lexical decision task performance
2 days at age 18
Study Arms (1)
healthy 18 year old males
Eligibility Criteria
random sampling of representative sample of 18 year old men in the area of Dresden
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Carl Gustav Carus
Dresden, Saxony, 01307, Germany
Related Publications (1)
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.
PMID: 28675116DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ulrich Zimmermann, PD Dr.
University Hospital Carl Gustav Carus at TU Dresden
- PRINCIPAL INVESTIGATOR
Michael Smolka, Prof. Dr.
Section of Systems Neuroscience at TU Dresden
- STUDY CHAIR
Hans-Ulrich Wittchen, Prof. Dr.
TU Dresden
- STUDY CHAIR
Andreas Heinz, Prof. Dr.
Charite University, Berlin, Germany
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2013
First Posted
May 21, 2013
Study Start
June 1, 2013
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
February 12, 2015
Record last verified: 2015-02