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Possible Effects of Energy Drink Ingestion on Perceived Alcohol Intoxication

Primary Purpose

Perceived Alcohol Intoxication

Status

Unknown status

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

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)

About this trial

This is an interventional treatment trial for Perceived Alcohol Intoxication focused on measuring energy drinks, alcohol intoxication

Eligibility Criteria

20 Years - 26 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Medical University of Vienna, Deparment of pediatric and adolescent medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

Placebo

Comparator 1 (with alcohol)

Comparator 2 (with alcohol and coffeine)

Comparator 3 (with alcohol and energy drink)

Arm Description

Outcomes

Primary Outcome Measures

Changes in breath alcohol concentration

Changes of subjective effects of intoxication

Secondary Outcome Measures

Safety and tolerability

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

Full Information

NCT ID

NCT01350089

First Posted

May 4, 2011

Last Updated

May 6, 2011

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT01350089

Brief Title

Possible Effects of Energy Drink Ingestion on Perceived Alcohol Intoxication

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2011

Overall Recruitment Status

Unknown status

Study Start Date

January 2011 (undefined)

Primary Completion Date

May 2012 (Anticipated)

Study Completion Date

May 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Medical University of Vienna

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Perceived Alcohol Intoxication

Keywords

energy drinks, alcohol intoxication

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

Comparator 1 (with alcohol)

Arm Type

Active Comparator

Arm Title

Comparator 2 (with alcohol and coffeine)

Arm Type

Active Comparator

Arm Title

Comparator 3 (with alcohol and energy drink)

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Placebo (without alcohol, caffeine, energy drink)

Intervention Description

(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

Intervention Name(s)

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

Intervention Description

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

Intervention Name(s)

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

Intervention Description

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

Intervention Name(s)

Comparator 3 (with alcohol and energy drink)

Intervention Description

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 Outcome Measure Information:

Title

Changes in breath alcohol concentration

Time Frame

from baseline up to 150 minutes

Title

Changes of subjective effects of intoxication

Time Frame

from baseline up to 120 minutes

Secondary Outcome Measure Information:

Title

Safety and tolerability

Description

Safety and tolerability will be monitored by measurement of vital signs, in particular pulse, and review of adverse events.

Time Frame

participants will be followed for the whole testing period of an expected average of 5 hours

Title

Changes in Supine and standing vital signs

Time Frame

from baseline up to 150 minutes

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

26 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christoph Aufricht, Univ.Prof.Dr.

Organizational Affiliation

Medical University of Vienna

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of Vienna, Deparment of pediatric and adolescent medicine

City

Vienna

ZIP/Postal Code

1090

Country

Austria

12. IPD Sharing Statement

Links:

URL

http://www.meduniwien.ac.at

Description

Homepage MUVienna

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Possible Effects of Energy Drink Ingestion on Perceived Alcohol Intoxication

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