Possible Effects of Energy Drink Ingestion on Perceived Alcohol Intoxication

Not Applicable

• Conditions: Perceived Alcohol Intoxication
• Interventions: Drug: Placebo (without alcohol, caffeine, energy drink); Drug: Comparator 1 (with alcohol; without caffeine and energy drink); Drug: Comparator 2 (with alcohol and caffeine; without energy drink); Drug: Comparator 3 (with alcohol and energy drink)

• Registration Number: NCT01350089
• Lead Sponsor: Medical University of Vienna

Brief Summary

The purpose of this study is to determine whether the ingestion of caffeine, Energy Drinks has an effect on perceived alcohol intoxication.

Detailed Description

In each of the four study periods, subjects will receive one of the four study treatments in a double blind, randomised, manner. The effects of study treatment on alcohol intoxication will be determined by measurement of breath alcohol concentration and subjective effects of intoxication. Safety and tolerability will be monitored by measurement of vital signs, in particular pulse, and review of adverse events.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-01
• Status Verified: 2011-05
• Study First Submitted: 2011-05-04
• Study First Submitted QC: 2011-05-06
• Last Update Submitted: 2011-05-06
• Study First Posted: 2011-05-09
• Last Update Posted: 2011-05-09
• Primary Completion: 2012-05
• Study Completion: 2012-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 52

Inclusion Criteria

• Healthy male volunteers
• Able and willing to comply with the requirements of the study, confirmed by written informed consent
• Aged 20 to 26 years
• Within acceptable range for weight and body mass index (70-85 kg and 21 to 25 kg/m2)
• At least 12-14 years of formal education
• In good general health as determined by medical history and screening investigations (see below)
• Taking no regular medication
• No history of psychiatric disorders
• Moderate alcohol consumption (less than 190.4 g/week) according to the Daily Drink questionnaire (Collins et a., 1985)
• "sporadic" users of Energy Drinks (fewer than 10 cans of 250 ml in the last 6 months)
• Confirmation that the general practitioner/primary care physician knows no reason that would prevent their participation
• Similar in social and demographic data, similar quality of life
• similar patterns of use of alcoholic beverages and Energy Drinks as well as quality of life (Martinez et al., 2000)
• similar level of physical activity (physical activity questionnaire) (Baecke et al., 1982)

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Exclusion Criteria

• Any condition that the investigator and/or sponsor consider might increase the risk to the volunteer or decrease the chance of obtaining satisfactory data
• Consumed 2>x>4 caffeine-containing drinks/day within 3 months of screening
• Smoked >10 cigarettes/day or equivalent within 3 months of screening
• Consumed more than 190.4 g alcohol per week, or have a history of alcohol or drug abuse or
• Consumed less than one alcoholic drink per week

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo (without alcohol, caffeine, energy drink)	-
Comparator 1 (with alcohol)	Comparator 1 (with alcohol; without caffeine and energy drink)	-
Comparator 2 (with alcohol and coffeine)	Comparator 2 (with alcohol and caffeine; without energy drink)	-
Comparator 3 (with alcohol and energy drink)	Comparator 3 (with alcohol and energy drink)	-

Primary Outcome Measures

Name	Time	Method
Changes in breath alcohol concentration	from baseline up to 150 minutes
Changes of subjective effects of intoxication	from baseline up to 120 minutes

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability	participants will be followed for the whole testing period of an expected average of 5 hours	Safety and tolerability will be monitored by measurement of vital signs, in particular pulse, and review of adverse events.
Changes in Supine and standing vital signs	from baseline up to 150 minutes

Trial Locations

Locations (1)

Medical University of Vienna, Deparment of pediatric and adolescent medicine; 🇦🇹 Vienna, Austria