Effects of Beer (Alcohol) on Social Cognition

NCT ID: NCT02318823

Last Updated: 2015-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-09-30

Brief Summary

The present study aims to evaluate effects of beer (alcohol) on social cognition.

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: OTHER

Beer (alcoholic)

Intervention Type: OTHER

Beer (individually calculated amount aiming to achieve a blood-alcohol-centration of 0.4g/kg)

Placebo (non-alcoholic beer)

Intervention Type: OTHER

Non-alcoholic beer serves as Placebo.

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.

Group Type: OTHER

Beer (alcoholic)

Intervention Type: OTHER

Beer (individually calculated amount aiming to achieve a blood-alcohol-centration of 0.4g/kg)

Placebo (non-alcoholic beer)

Intervention Type: OTHER

Non-alcoholic beer serves as Placebo.

Interventions

Beer (alcoholic)

Beer (individually calculated amount aiming to achieve a blood-alcohol-centration of 0.4g/kg)

Intervention Type: OTHER

Placebo (non-alcoholic beer)

Non-alcoholic beer serves as Placebo.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthias E Liechti, MD, MAS

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

University Hospital Basel

Basel, , Switzerland

Countries

Switzerland

References

Dolder PC, Holze F, Liakoni E, Harder S, Schmid Y, Liechti ME. Alcohol acutely enhances decoding of positive emotions and emotional concern for positive stimuli and facilitates the viewing of sexual images. Psychopharmacology (Berl). 2017 Jan;234(1):41-51. doi: 10.1007/s00213-016-4431-6. Epub 2016 Sep 19.

Reference Type: DERIVED

PMID: 27640999 (View on PubMed)

Other Identifiers

EKNZ 2014-369

Identifier Type: -

Identifier Source: org_study_id