Effects of Beer (Alcohol) on Social Cognition

Healthy Clinical Trial

Official title:

Effects of Beer (Alcohol) on Social Cognition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02318823
• Other study ID #: EKNZ 2014-369
• Status: Completed
• Phase: N/A
• First received: December 12, 2014
• Last updated: September 24, 2015
• Start date: December 2014
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Beer (alcoholic)
Beer (individually calculated amount aiming to achieve a blood-alcohol-centration of 0.4g/kg)
• Placebo (non-alcoholic beer)
Non-alcoholic beer serves as Placebo.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of beer (alcohol) on emotion recognition		3 hours	No
Secondary	Effect of beer (alcohol) on empathy and social behavior		3 hours	No
Secondary	Subjective effects of beer (alcohol)		3 hours	No
Secondary	Effect of beer (alcohol) on appraisal of visual erotic stimuli		3 hours	No
Secondary	Effects of beer (alcohol) on plasma oxytocin		3 hours	No
Secondary	Effect modulation by genetic polymorphisms		3 hours	No