Interaction of Alcohol With Energy Drinks

Study Overview
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Brief Summary
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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.

Detailed Description
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Consumption of energy drinks improve psychomotor performance and alertness. These drinks contain mostly caffeine, taurine and vitamins. Its consumption associated with ethanol may reduce feelings of drunkenness as the stimulant effects of caffeine could counteract the depressing effects of ethanol on the central nervous system. Reducing the perception of intoxication may predispose the intoxicated person to engage in risky behaviors such as driving under the influence of ethanol and therefore can increase the risk of a traffic accident. Furthermore, the combination of both beverages may increase the risk of bleeding in case of injury as anticoagulant effects have been described for ethanol while antiplatelet effects have been described for caffeine and taurine. A randomized clinical trial will be performed in healthy volunteers administering 4 treatment conditions: alcohol+energy drink, alcohol+placebo of energy drink, placebo of alcohol+energy drink and placebo of alcohol+placebo of energy drink. A multiple dose will be administered separated by 1 hour.

Official Title
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Effects of Alcohol and Energy Drinks on Driving Performance and Bleeding Risk

Conditions
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Alcohol-Related Disorders, Drinking and Driving

Intervention / Treatment
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* Dietary Supplement: Alcohol and energy drink
* Dietary Supplement: Alcohol
* Dietary Supplement: Energy drink
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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 illegal substances or regular consumption of psychoactive drugs Having donated blood or having participated in this same study in the preceding 8 weeks, or having participated in any clinical trial with drugs in the preceding 12 weeks Having had any somatic disease or having undergone major surgery in the 3 months prior to inclusion in the trial Individuals intolerant or having experienced a severe adverse reaction to alcohol or energy drinks Having regularly taken medication in the month before the trial, except for vitamins, herb-based remedies, dietary supplements that if, according to the Principal Investigator or his appointed collaborators' opinion, they pose no threat to the subjects and they won't interfere with the study's objectives. Single doses of symptomatic drugs taken during the week before the experimental session will not constitute an exclusion criterion if it can be assumed that it has been completely eliminated on the day of the experimental session Smokers of >5 cigarettes/day Consumption of >20 g/day of alcohol (females) or of >40 g/day (males) Daily consumption of more than 5 coffees, teas, cola drinks or other stimulant or xanthine-containing beverages in the 3 months prior to inclusion in the study Hepatitis B, hepatitis C or human immunodeficiency virus-positive individuals Pregnant or lactating women, or those using hormonal or unreliable contraceptive methods during the study period. Complete abstinence, intrauterine devices, double barrier methods or a vasectomized sexual partner will be considered acceptable Women with amenorrhea or suffering severe premenstrual syndrome Individuals of Asian ascent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alcohol and energy drink<br>Alcohol 60 g, multiple dose (30 g+30 g), oral administration. 3 energy drinks (750 ml), multiple dose (375 ml+375 ml), oral administration. | Dietary Supplement: Alcohol and energy drink<br>* Multiple oral dose of alcohol Multiple oral dose of energy drink<br>|
| Active Comparator: Alcohol<br>Alcohol 60 g, multiple dose (30 g+30 g), oral administration. 3 non-caffeinated soft drinks (750 ml), multiple dose (375 ml+375 ml), oral administration. | Dietary Supplement: Alcohol<br>* Multiple oral dose of alcohol<br>|
| Active Comparator: Energy drink<br>3 energy drinks (750 ml), multiple dose (375 ml+ 375 ml), oral administration. Font Vella water (188ml), multiple dose (94 ml+ 94 ml), oral administration. | Dietary Supplement: Energy drink<br>* Multiple oral dose of energy drink<br>|
| Placebo Comparator: Placebo<br>3 non-caffeinated soft drinks (750 ml), multiple dose (375 ml+375 ml), oral administration. Font Vella water (188ml), multiple dose (94 ml+ 94 ml), oral administration. | Dietary Supplement: Placebo<br>* Multiple oral dose of water Multiple oral dose of non-caffeinated soft drink<br>* Other names: Non-active treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in tracking test performance | The total time outside the road will be measured in the tracking test | From baseline till 4 hours after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in simple reaction time (SRT) | Test will be performed using the computerized cognitive testing battery CANTAB and mean latency will be measured | From baseline till 4 hours after administration | 
| Change in movement estimation | The lapse of time between actual and predicted time will be measured in a movement estimation task | From baseline till 4 hours after administration | 
| Change in memory function | The N-Back test will be performed with 2 different options: 0 back test and 2 back test | From baseline till 4 hours after administration | 
| Change in drunkenness | Drunkenness will be measured using a visual analog scale (0-100 mm) | From baseline till 8 hours after administration | 
| Change in drowsiness | Drowsiness will be measured using a visual analog scale (0-100 mm) | From baseline till 8 hours after administration | 
| Change in headache | Headache will be measured using a visual analog scale (0-100 mm) | From baseline till 8 hours after administration | 
| Change in palpitations | Palpitations will be measured using a visual analog scale (0-100 mm) | From baseline till 8 hours after administration | 
| Change in anxiety | Anxiety will be measured using a visual analog scale (0-100 mm) | From baseline till 8 hours after administration | 
| Change in subjective effects measured with Addiction Research Center Inventory (ARCI) | Subjective effects of alcohol and caffeine will be measured using Addiction Research Center Inventory | From baseline till 8 hours after administration | 
| Change in subjective effects measured with Biphasic alcohol effects scale (BAES) | Subjective effects of alcohol will be measured using BAES | From baseline till 8 hours after administration | 
| Change in blood pressure | Systolic and diastolic blood pressure will be measured | From baseline till 8 hours after administration | 
| Change in heart rate | Heart rate will be measured | From baseline till 8 hours after administration | 
| Change in oral temperature | Oral temperature will be measured | From baseline till 8 hours after administration | 
| Number of participants with serious and non-serious adverse events | Collection of adverse effects spontaneously reported by the participants and/or observed by the investigators | From inclusion till one week after the last experimental session | 
| Area under the concentration-time curve (AUC 0-8h) of ethanol blood concentrations | Calculation of AUC of ethanol concentrations obtained baseline and 0.25, 0.50h , 0.75, 1, 1.50, 1.75, 2, 2.25, 2.5, 3, 4, 6 and 8h after administration | From baseline till 8 hours after administration | 
| Area under the concentration-time curve (AUC 0-8h) of taurine blood concentrations | Calculation of AUC of ethanol concentrations obtained baseline and 0.50,1, 1.50, 2, 4, 6 and 8h after administration | From baseline till 8 hours after administration | 
| Area under the concentration-time curve (AUC 0-8h) of caffeine blood concentrations | Calculation of AUC of ethanol concentrations obtained baseline and 0,25, 0.50,1, 1.50, 2, 3, 4, 6 and 8h after administration | From baseline till 8 hours after administration | 
| Area under the concentration-time curve (AUC 0-8h) of ethanol breath air concentrations | Calculation of AUC of ethanol concentrations obtained baseline and 0.25, 0.50, 0.75,1, 1.50, 1.75, 2, 2.25, 2.5, 3, 4, 6 and 8h after administration | From baseline till 8 hours after administration | 
| Maximum concentration (Cmax) of taurine |  | From baseline till 8 hours after administration | 
| Maximum concentration (Cmax) of ethanol |  | From baseline till 8 hours after administration | 
| Maximum concentration (Cmax) of caffeine |  | From baseline till 8 hours after administration | 
| Time to reach maximum concentration (tmax) of ethanol |  | From baseline till 8 hours after administration | 
| Time to reach maximum concentration (tmax) of caffeine |  | From baseline till 8 hours after administration | 
| Time to reach maximum concentration (tmax) of taurine |  | From baseline till 8 hours after administration | 
| Blood coagulation prothrombin | Prothrombin time (PT) and ratio will be measured | From baseline till 2 hours after administration | 
| Blood coagulation thromboplastin | Activated partial thromboplastin time (APTT) and ratio will be measured | From baseline till 2 hours after administration | 
| Platelet aggregation (function) | Platelet function (PFA) will be measured | From baseline till 2 hours after administration | 
| Platelet count | Platelet count will be measured | From baseline till 2 hours after administration | 
| Change in willingness to drive | Willingness to drive in 3 different situations will be measured by means of a visual analog scale | From baseline till 6 hours after administration | 
| Like the drug (drink) | Drug liking will be measured using a visual analog scale (0-100 mm) | At the end of each experimental session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alcohol, energy drink, coagulability, caffeine, taurine, driving performance