HealthyNCT02318823
Effects of Beer (Alcohol) on Social Cognition
A study testing Beer (alcoholic) in people with Healthy, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The present study aims to evaluate effects of beer (alcohol) on social cognition. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Beer (alcoholic)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
The present study aims to evaluate effects of beer (alcohol) on social cognition.
Read the 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
- Being tested
- Beer (alcoholic), Placebo (non-alcoholic beer)
- Keywords
- social neuroscience, emotion, face recognition, empathy, beer, alcohol, social cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beer (alcoholic)Other
Beer (individually calculated amount aiming to achieve a blood-alcohol-centration of 0.4g/kg)
Placebo (non-alcoholic beer)Other
Non-alcoholic beer serves as Placebo.
| Study group | Role | What they receive |
|---|---|---|
| Beer (alcoholic) followed by placebo (non-alcoholic) | Other | Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has two treatment conditions in the same subject. Receives: Other: Beer (alcoholic); Other: Placebo (non-alcoholic beer) |
| Placebo (non-acoholic beer) followed by Beer (alcoholic) | Other | Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has two treatment conditions in the same subject. Receives: Other: Beer (alcoholic); Other: Placebo (non-alcoholic beer) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of beer (alcohol) on emotion recognition
Measured: 3 hours
Secondary outcomes (5)
Effect of beer (alcohol) on empathy and social behavior
Measured: 3 hours
Subjective effects of beer (alcohol)
Measured: 3 hours
Effect of beer (alcohol) on appraisal of visual erotic stimuli
Measured: 3 hours
Effects of beer (alcohol) on plasma oxytocin
Measured: 3 hours
Effect modulation by genetic polymorphisms
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthias E Liechti, MD, MAS, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02318823
- Sponsor's protocol ID
- EKNZ 2014-369
- Status last verified
- Sep 2015
- First submitted
- 12 Dec 2014
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27640999
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Beer (Alcohol) on Social Cognition
- ClinicalTrials.gov ID
- NCT02318823
- Acronym / sponsor ID
- EKNZ 2014-369
- Conditions
- Healthy
- Keywords
- social neuroscience, emotion, face recognition, empathy, beer, alcohol, social cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 17 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beer (alcoholic) followed by placebo (non-alcoholic) | Other | Other: Beer (alcoholic), Other: Placebo (non-alcoholic beer)Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has two treatment conditions in the same subject. |
| Placebo (non-acoholic beer) followed by Beer (alcoholic) | Other | Other: Beer (alcoholic), Other: Placebo (non-alcoholic beer)Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has two treatment conditions in the same subject. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beer (alcoholic)Beer (individually calculated amount aiming to achieve a blood-alcohol-centration of 0.4g/kg) | Other | Beer (alcoholic) followed by placebo (non-alcoholic), Placebo (non-acoholic beer) followed by Beer (alcoholic) |
| Placebo (non-alcoholic beer)Non-alcoholic beer serves as Placebo. | Other | Beer (alcoholic) followed by placebo (non-alcoholic), Placebo (non-acoholic beer) followed by Beer (alcoholic) |
Primary outcome
Effect of beer (alcohol) on emotion recognition
Time frame: 3 hours
5 secondary outcomes
Effect of beer (alcohol) on empathy and social behavior
Time frame: 3 hours
Subjective effects of beer (alcohol)
Time frame: 3 hours
Effect of beer (alcohol) on appraisal of visual erotic stimuli
Time frame: 3 hours
Effects of beer (alcohol) on plasma oxytocin
Time frame: 3 hours
Effect modulation by genetic polymorphisms
Time frame: 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
- Derived from this study: PubMed 27640999Dolder 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias E Liechti, MD, MAS principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beer (alcoholic) in people with Healthy, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of beer (alcohol) on emotion recognition (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02318823, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2015.