Possible Effects of Energy Drink Ingestion on Perceived Alcohol Intoxication

May 6, 2011 updated by: Medical University of Vienna

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Changes in breath alcohol concentration
Time Frame: from baseline up to 150 minutes
from baseline up to 150 minutes
Changes of subjective effects of intoxication
Time Frame: from baseline up to 120 minutes
from baseline up to 120 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety and tolerability
Time Frame: participants will be followed for the whole testing period of an expected average of 5 hours
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
Time Frame: from baseline up to 150 minutes
from baseline up to 150 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Vienna

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christoph Aufricht, Univ.Prof.Dr., Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2011

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2012

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ED and alcohol intoxication

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