Clinical trial NCT02318823: Effects of Beer (Alcohol) on Social Cognition
Official title: Effects of Beer (Alcohol) on Social Cognition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: social neuroscience
emotion
face recognition
empathy
beer
alcohol
social cognition
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2014-12-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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).

Primary outcomes:
measure: Effect of beer (alcohol) on emotion recognition
timeFrame: 3 hours
Secondary outcomes:
measure: Effect of beer (alcohol) on empathy and social behavior
timeFrame: 3 hours
measure: Subjective effects of beer (alcohol)
timeFrame: 3 hours
measure: Effect of beer (alcohol) on appraisal of visual erotic stimuli
timeFrame: 3 hours
measure: Effects of beer (alcohol) on plasma oxytocin
timeFrame: 3 hours
measure: Effect modulation by genetic polymorphisms
timeFrame: 3 hours
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Matthias E Liechti, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.