Possible Effects of Energy Drink Ingestion on Perceived Alcohol Intoxication

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

Detailed Description
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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.

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

Conditions
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Perceived Alcohol Intoxication

Intervention / Treatment
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* 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)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo (without alcohol, caffeine, energy drink)<br>* (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.<br>|
| Active Comparator: Comparator 1 (with alcohol)<br> | Drug: Comparator 1 (with alcohol; without caffeine and energy drink)<br>* 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.<br>|
| Active Comparator: Comparator 2 (with alcohol and coffeine)<br> | Drug: Comparator 2 (with alcohol and caffeine; without energy drink)<br>* 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.<br>|
| Experimental: Comparator 3 (with alcohol and energy drink)<br> | Drug: Comparator 3 (with alcohol and energy drink)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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energy drinks, alcohol intoxication