Clinical Trial: Possible Effects of Energy Drink Ingestion on Perceived Alcohol Intoxication
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
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
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 Summary: 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.
Sponsor: Medical University of Vienna
Current Primary Outcome:
- 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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.
- Changes in Supine and standing vital signs [ Time Frame: from baseline up to 150 minutes ]
Original Secondary Outcome: Same as current
Information By: Medical University of Vienna
Dates:
Date Received: May 4, 2011
Date Started: January 2011
Date Completion: May 2012
Last Updated: May 6, 2011
Last Verified: May 2011
