Clinical trial NCT01858818: Project 4: Acute Effects of Alcohol on Learning and Habitization in Healthy Young Adults
Official title: Project 4: Acute Effects of Alcohol on Learning and Habitization in Healthy Young Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcoholism
Keywords: CAIS Computer Assisted Infusion System
real life drinking behavior
family history of alcoholism
conditioning
instrumental learning
habitization
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2013-05-21
Enrollment: 75
Sex: MALE
Minimum age (years): 18
Maximum age (years): 18
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: random sampling of representative sample of 18 year old men in the area of 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.

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

Primary outcomes:
measure: individual learning parameters
timeFrame: 2 days at age 18
Secondary outcomes:
measure: individual approach/avoidance reaction time differences
timeFrame: 2 days at age 18
Other outcomes:
measure: lexical decision task performance
timeFrame: 2 days at age 18
Locations:
city: Dresden
country: Germany
facility: University Hospital Carl Gustav Carus
state: Saxony
Study officials:
affiliation: University Hospital Carl Gustav Carus at TU Dresden
name: Ulrich Zimmermann, PD Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Section of Systems Neuroscience at TU Dresden
name: Michael Smolka, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: TU Dresden
name: Hans-Ulrich Wittchen, Prof. Dr.
role: STUDY_CHAIR
affiliation: Charite University, Berlin, Germany
name: Andreas Heinz, Prof. Dr.
role: STUDY_CHAIR
References:
citation: 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.