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

Completed

• Conditions: Alcoholism

• Registration Number: NCT01858818
• Lead Sponsor: Technische Universität Dresden

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.

Study Timeline

• Study First Submitted: 2013-05-17
• Study First Submitted QC: 2013-05-17
• Study First Posted: 2013-05-21
• Study Start: 2013-06
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-11
• Last Update Posted: 2015-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 75

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
individual learning parameters	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

Secondary Outcome Measures

Name	Time	Method
individual approach/avoidance reaction time differences	2 days at age 18	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

Trial Locations

Locations (1)

University Hospital Carl Gustav Carus; 🇩🇪 Dresden, Saxony, Germany