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

Alcoholism Clinical Trial

— LeAD_P4  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01858818
• Other study ID #: ZI 1119/4-1
• Status: Completed
• Phase: N/A
• First received: May 17, 2013
• Last updated: February 11, 2015
• Start date: June 2013
• Est. completion date: October 2014

Study information

• Verified date: February 2015
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 18 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Alcoholism

Locations

Country	Name	City	State
Germany	University Hospital Carl Gustav Carus	Dresden	Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	lexical decision task performance	when deciding whether a word is a real word or not, accuracy should go down and reaction times up when people are alcoholized vs. sober the variable is used as a measure for general impairment of decision making and RT under alcohol	2 days at age 18	No
Primary	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	No
Secondary	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	2 days at age 18	No