Overview

This trial is active, not recruiting.

Condition perceived alcohol intoxication
Treatments placebo (without alcohol, caffeine, energy drink), comparator 1 (with alcohol; without caffeine and energy drink), comparator 2 (with alcohol and caffeine; without energy drink), comparator 3 (with alcohol and energy drink)
Sponsor Medical University of Vienna
Start date January 2011
End date May 2012
Trial size 52 participants
Trial identifier NCT01350089, ED and alcohol intoxication

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
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; 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 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)
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.

Primary Outcomes

Measure
Changes in breath alcohol concentration
time frame: from baseline up to 150 minutes
Changes of subjective effects of intoxication
time frame: from baseline up to 120 minutes

Secondary Outcomes

Measure
Safety and tolerability
time frame: participants will be followed for the whole testing period of an expected average of 5 hours
Changes in Supine and standing vital signs
time frame: from baseline up to 150 minutes

Eligibility Criteria

Male participants from 20 years up to 26 years old.

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

Additional Information

Official title A Double Blind, Randomised, Placebo-controlled, Within-subject Crossover Study to Examine the Possible Effects of Energy Drink Ingestion on Perceived Alcohol Intoxication
Principal investigator Christoph Aufricht, Univ.Prof.Dr.
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2011.
Information provided to ClinicalTrials.gov by Medical University of Vienna.