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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Comparator 1 (with alcohol) | Active Comparator |
| |
| Comparator 2 (with alcohol and coffeine) | Active Comparator |
| |
| Comparator 3 (with alcohol and energy drink) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo (without alcohol, caffeine, energy drink) | Drug | (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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Aufricht, Univ.Prof.Dr. | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna, Deparment of pediatric and adolescent medicine | Vienna | 1090 | Austria |
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| Label | URL |
|---|---|
| Homepage MUVienna | View source |
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| Comparator 1 (with alcohol; without caffeine and energy drink) | Drug | 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. |
|
| Comparator 2 (with alcohol and caffeine; without energy drink) | Drug | 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. |
|
| Comparator 3 (with alcohol and energy drink) | Drug | Mixture of 46.5 g ethanol (inform of vodka (37.5%)), Red BullĀ® 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. |
|
| from baseline up to 150 minutes |
| ID | Term |
|---|---|
| D000435 | Alcoholic Intoxication |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D002110 | Caffeine |
| D061215 | Energy Drinks |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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