- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02318823
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
Intervention / Treatment
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:
- Age between 18 and 50 years
- Sufficient understanding of the German language
- Subjects understand the procedures and the risks associated with the study
- Participants must be willing to adhere to the protocol and sign the consent form
- Participants must be willing to refrain from drinking alcohol in the evening preceding the study session
- Participants must be willing to abstain from excessive drinking and from taking illicit psychoactive drugs during the study.
- 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
- Participants must be willing not to drive a traffic vehicle or to operate machines for 3h after the sessions
- Women must have a negative pregnancy test at the beginning of each session.
Exclusion Criteria:
- Chronic or acute medical condition.
- Current or previous personal history of psychotic or major affective disorder.
- Prior or current alcohol abuse, dangerous drinking behavior (>15 points in the AUDIT questionnaire).
- Family history of alcoholism (first-degree relative).
- Alcohol hypersensitivity
- Prior illicit drug use (except Tetrahydrocannabinol (THC)-containing products) more than 15 times or any time within the previous week.
- Use of medications that are contraindicated or interfere otherwise with the effects of the study (monoamine oxidase inhibitors, antidepressants, sedatives etc.)
- Pregnant or nursing women.
- 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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