NCT01858818

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 21, 2013

Completed
11 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

February 12, 2015

Status Verified

February 1, 2015

Enrollment Period

1.3 years

First QC Date

May 17, 2013

Last Update Submit

February 11, 2015

Conditions

Keywords

CAIS Computer Assisted Infusion Systemreal life drinking behaviorfamily history of alcoholismconditioninginstrumental learninghabitization

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

Age18 Years - 18 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

Location

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.

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR
  • Hans-Ulrich Wittchen, Prof. Dr.

    TU Dresden

    STUDY CHAIR
  • Andreas Heinz, Prof. Dr.

    Charite University, Berlin, Germany

    STUDY CHAIR

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

Locations