NCT02318823

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 17, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 28, 2015

Status Verified

September 1, 2015

Enrollment Period

9 months

First QC Date

December 12, 2014

Last Update Submit

September 24, 2015

Conditions

Healthy

Keywords

social neuroscienceemotionface recognitionempathybeeralcoholsocial cognition

Outcome Measures

Primary Outcomes (1)

  • Effect of beer (alcohol) on emotion recognition

    3 hours

Secondary Outcomes (5)

  • Effect of beer (alcohol) on empathy and social behavior

    3 hours

  • Subjective effects of beer (alcohol)

    3 hours

  • Effect of beer (alcohol) on appraisal of visual erotic stimuli

    3 hours

  • Effects of beer (alcohol) on plasma oxytocin

    3 hours

  • Effect modulation by genetic polymorphisms

    3 hours

Study Arms (2)

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.

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.

Other: Beer (alcoholic)Other: Placebo (non-alcoholic beer)

Interventions

Beer (alcoholic)OTHER

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

Beer (alcoholic) followed by placebo (non-alcoholic)Placebo (non-acoholic beer) followed by Beer (alcoholic)
Placebo (non-alcoholic beer)OTHER

Non-alcoholic beer serves as Placebo.

Beer (alcoholic) followed by placebo (non-alcoholic)Placebo (non-acoholic beer) followed by Beer (alcoholic)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 27640999DERIVED

MeSH Terms

Interventions

Beer

Intervention Hierarchy (Ancestors)

Alcoholic BeveragesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFermented BeveragesFermented FoodsFood and Beverages

Study Officials

  • Matthias E Liechti, MD, MAS

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2014

First Posted

December 17, 2014

Study Start

December 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

September 28, 2015

Record last verified: 2015-09

Locations

CH(1)