Possible Effects of Energy Drink Ingestion on Perceived Alcohol Intoxication

A Double Blind, Randomised, Placebo-controlled, Within-subject Crossover Study to Examine the Possible Effects of Energy Drink Ingestion on Perceived Alcohol Intoxication

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

Study Overview

• Status: Unknown
• Conditions: Perceived Alcohol Intoxication
• Intervention / Treatment: 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)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University of Vienna, Deparment of pediatric and adolescent medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 26 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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)

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo (without alcohol, caffeine, energy drink); (carbonated) water (volume equivalent to 46.5 g ethanol (inform of vodka (37.5%)) (carbonated) water (250 ml), artificial fruit juice (21 g/L prepared with (carbonated) water). The final volume of the mixture is 500 mL.
ACTIVE_COMPARATOR: Comparator 1 (with alcohol)	Drug: Comparator 1 (with alcohol; without caffeine and energy drink); Mixture of 46.5 g ethanol (inform of vodka (37.5%)), (carbonated) water 250 mL, artificial fruit juice (21 g/L prepared with (carbonated) water). The final volume of the mixture 500 mL.
ACTIVE_COMPARATOR: Comparator 2 (with alcohol and coffeine)	Drug: Comparator 2 (with alcohol and caffeine; without energy drink); Mixture of 46.5 g ethanol (inform of vodka (37.5%)), caffeine (80 mg), (carbonated) water (250 ml), artificial fruit juice (21 g/L prepared with (carbonated) water) The final volume of the mixture is 500 mL.
EXPERIMENTAL: Comparator 3 (with alcohol and energy drink)	Drug: Comparator 3 (with alcohol and energy drink); Mixture of 46.5 g ethanol (inform of vodka (37.5%)), Red Bull® Energy Drink (250 mL, without flavour mixture to optimize blinding), artificial fruit juice (21 g/L prepared with (carbonated) water).The final volume of the mixture is 500 mL.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Christoph Aufricht, Univ.Prof.Dr., Medical University of Vienna

Publications and helpful links

Helpful Links

• Homepage MUVienna

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ANTICIPATED): May 1, 2012
• Study Completion (ANTICIPATED): May 1, 2012

Study Registration Dates

• First Submitted: May 4, 2011
• First Submitted That Met QC Criteria: May 6, 2011
• First Posted (ESTIMATE): May 9, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): May 9, 2011
• Last Update Submitted That Met QC Criteria: May 6, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: energy drinks; alcohol intoxication
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholic Intoxication; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Ethanol; Caffeine
• Other Study ID Numbers: ED and alcohol intoxication