Project 4: Acute Effects of Alcohol on Learning and Habitization in Healthy Young Adults

NCT ID: NCT01858818

Last Updated: 2015-02-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-10-31

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

healthy 18 year old males

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

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)
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Technische Universität Dresden

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ulrich Zimmermann, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Carl Gustav Carus at TU Dresden

Michael Smolka, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Section of Systems Neuroscience at TU Dresden

Hans-Ulrich Wittchen, Prof. Dr.

Role: STUDY_CHAIR

TU Dresden

Andreas Heinz, Prof. Dr.

Role: STUDY_CHAIR

Charite University, Berlin, Germany

Locations

University Hospital Carl Gustav Carus

Dresden, Saxony, Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 28675116 (View on PubMed)

Other Identifiers

ZI 1119/4-1

Identifier Type: -

Identifier Source: org_study_id