Effects of Beer (Alcohol) on Social Cognition

September 24, 2015 updated by: University Hospital, Basel, Switzerland
The present study aims to evaluate effects of beer (alcohol) on social cognition.

Study Overview

Status

Completed

Conditions

Detailed Description

Alcohol is one of the most widely used recreational drugs and it is often used in social settings to enhance sociability. There are few data showing that acute alcohol consumption affects facial emotion recognition. However the acute effects of alcohol in social drinkers on different aspects of social cognition are largely unknown. In the present study, we will therefore evaluate effects of beer (alcohol) on social cognition. The study will include 60 subjects (30 male, 30 female) and use a placebo-controlled, crossover design with the two experimental conditions alcoholic beer (individually calculated amount aiming to achieve a blood-alcohol concentration of 0.4g/kg), and non-alcoholic beer (placebo). We primarily aim to evaluate whether beer (alcohol) affects the ability to correctly decode emotions in facial expressions using different facial emotion recognition Tasks. Additionally, appraisal of visual erotic stimuli following alcohol consumption will be evaluated. Subjective social and mood effects will be assessed using validated questionnaires. Blood samples will be collected to assess plasma levels of the "social hormone" oxytocin as well as blood alcohol levels to test possible associations with effects on emotional processing.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Basel, Switzerland
        • University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age between 18 and 50 years
  2. Sufficient understanding of the German language
  3. Subjects understand the procedures and the risks associated with the study
  4. Participants must be willing to adhere to the protocol and sign the consent form
  5. Participants must be willing to refrain from drinking alcohol in the evening preceding the study session
  6. Participants must be willing to abstain from excessive drinking and from taking illicit psychoactive drugs during the study.
  7. Participants must be willing not to eat or drink xanthine-containing liquids (such as coffee, black or green tea, red bull, chocolate) 3 h prior to the study session
  8. Participants must be willing not to drive a traffic vehicle or to operate machines for 3h after the sessions
  9. Women must have a negative pregnancy test at the beginning of each session.

Exclusion Criteria:

  1. Chronic or acute medical condition.
  2. Current or previous personal history of psychotic or major affective disorder.
  3. Prior or current alcohol abuse, dangerous drinking behavior (>15 points in the AUDIT questionnaire).
  4. Family history of alcoholism (first-degree relative).
  5. Alcohol hypersensitivity
  6. Prior illicit drug use (except Tetrahydrocannabinol (THC)-containing products) more than 15 times or any time within the previous week.
  7. Use of medications that are contraindicated or interfere otherwise with the effects of the study (monoamine oxidase inhibitors, antidepressants, sedatives etc.)
  8. Pregnant or nursing women.
  9. Participation in another clinical trial (currently or within the last 30 days).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Beer (alcoholic) followed by placebo (non-alcoholic)
Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has two treatment conditions in the same subject.
Beer (individually calculated amount aiming to achieve a blood-alcohol-centration of 0.4g/kg)
Non-alcoholic beer serves as Placebo.
Other: Placebo (non-acoholic beer) followed by Beer (alcoholic)
Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has two treatment conditions in the same subject.
Beer (individually calculated amount aiming to achieve a blood-alcohol-centration of 0.4g/kg)
Non-alcoholic beer serves as Placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect of beer (alcohol) on emotion recognition
Time Frame: 3 hours
3 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Effect of beer (alcohol) on empathy and social behavior
Time Frame: 3 hours
3 hours
Subjective effects of beer (alcohol)
Time Frame: 3 hours
3 hours
Effect of beer (alcohol) on appraisal of visual erotic stimuli
Time Frame: 3 hours
3 hours
Effects of beer (alcohol) on plasma oxytocin
Time Frame: 3 hours
3 hours
Effect modulation by genetic polymorphisms
Time Frame: 3 hours
3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Matthias E Liechti, MD, MAS, University Hospital, Basel, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

December 12, 2014

First Submitted That Met QC Criteria

December 12, 2014

First Posted (Estimate)

December 17, 2014

Study Record Updates

Last Update Posted (Estimate)

September 28, 2015

Last Update Submitted That Met QC Criteria

September 24, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • EKNZ 2014-369

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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