Interaction of Alcohol With Energy Drinks (NCT02771587) | Clinical Trial Compass
CompletedPhase 1
Interaction of Alcohol With Energy Drinks
Spain16 participantsStarted 2016-06
Plain-language summary
The main objective of the project is to assess whether there is an interaction between the effects of ethanol and energy drinks on driving performance.
Secondary objectives include: to evaluate subjective effects (drunkenness) after administration of alcohol and energy drinks, to assess pharmacokinetics of alcohol, caffeine and taurine after alcohol and energy drinks administration and to assess if there is an increased risk of bleeding when both drinks are taken together.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion Criteria:
* Understand and accept the study's procedures and sign an informed consent form
* No evidence of somatic or psychiatric disorders as per past medical history and physical examination
* EKG, blood and urine tests taken before entry into the study within the normal range. Minor and transient abnormalities may be acceptable if, according to the Principal Investigator's criterion and the state of the art, they are felt to have no clinical relevance, entail no danger to the participant, and don't interfere with the product's assessment. These abnormalities and their non-relevance must be specifically justified in writing)
* Body mass index (BMI=weight/heigth2) between 19 and 27 kg/m2, weight between 50 and 100 kg
* For premenopausal females, a regular menstrual cycle of 26-32 days duration.
* Social or recreational alcohol consumption of at least 1 unit per day (or its equivalent \[7 units\] over the whole week) and having experienced drunkenness several times
* Regular consumption of beverages containing methylxanthines (at least 5 per week)
* Consumption of energy drinks several times previously
* Having a driving license
Exclusion Criteria:
* Evidence of a preexisting condition (including gastrointestinal, liver, or kidney disorders) that may alter the absorption, distribution, metabolism or excretion of the drug or symptoms suggestive of drug-induced gastrointestinal irritation
* Previous psychiatric disorders, alcoholism, abuse of prescription drugs or…
What they're measuring
1
Change in tracking test performance
Timeframe: From baseline till 4 hours after administration