Possible Effects of Energy Drink Ingestion on Perceived Alcohol Intoxication

NCT ID: NCT01350089

Last Updated: 2011-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-05-31

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.

Conditions

Perceived Alcohol Intoxication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo (without alcohol, caffeine, energy drink)

Intervention Type: DRUG

(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.

Comparator 1 (with alcohol)

Group Type: ACTIVE_COMPARATOR

Comparator 1 (with alcohol; without caffeine and energy drink)

Intervention Type: DRUG

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.

Comparator 2 (with alcohol and coffeine)

Group Type: ACTIVE_COMPARATOR

Comparator 2 (with alcohol and caffeine; without energy drink)

Intervention Type: DRUG

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.

Comparator 3 (with alcohol and energy drink)

Group Type: EXPERIMENTAL

Comparator 3 (with alcohol and energy drink)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Medical University of Vienna, Department of Pediatrics and Adolescent Medicine

Principal Investigators

Christoph Aufricht, Univ.Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

Medical University of Vienna, Deparment of pediatric and adolescent medicine

Vienna, , Austria

Countries

Austria

Related Links

http://www.meduniwien.ac.at

Homepage MUVienna

Other Identifiers

ED and alcohol intoxication

Identifier Type: -

Identifier Source: org_study_id