Possible Effects of Energy Drink Ingestion on Perceived Alcohol Intoxication

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Medical University of Vienna.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01350089
First received: May 4, 2011
Last updated: May 6, 2011
Last verified: May 2011
  Purpose

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


Condition Intervention
Perceived Alcohol Intoxication
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)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Changes in breath alcohol concentration [ Time Frame: from baseline up to 150 minutes ] [ Designated as safety issue: No ]
  • Changes of subjective effects of intoxication [ Time Frame: from baseline up to 120 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability [ Time Frame: participants will be followed for the whole testing period of an expected average of 5 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: from baseline up to 150 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 52
Study Start Date: January 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 26 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01350089

Locations
Austria
Medical University of Vienna, Deparment of pediatric and adolescent medicine
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Christoph Aufricht, Univ.Prof.Dr. Medical University of Vienna
  More Information

Additional Information:
No publications provided

Responsible Party: Univ. Prof. Dr. Christoph Aufricht, Medical University of Vienna, Department of Pediatrics and Adolescent Medicine
ClinicalTrials.gov Identifier: NCT01350089     History of Changes
Other Study ID Numbers: ED and alcohol intoxication
Study First Received: May 4, 2011
Last Updated: May 6, 2011
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
energy drinks
alcohol intoxication

Additional relevant MeSH terms:
Alcoholic Intoxication
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Caffeine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Central Nervous System Stimulants
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on October 01, 2014