AEDED: Interaction of Alcohol With Energy Drinks

Sponsor

Parc de Salut Mar (Other)

Overall Status

Completed

CT.gov ID

NCT02771587

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol-Related Disorders Drinking and Driving	Dietary Supplement: Alcohol and energy drink Dietary Supplement: Alcohol Dietary Supplement: Energy drink Dietary Supplement: Placebo	Phase 1

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Jun 1, 2016

Actual Primary Completion Date :

Sep 1, 2016

Actual Study Completion Date :

Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Alcohol and energy drink 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 Multiple oral dose of alcohol Multiple oral dose of energy drink
Active Comparator: Alcohol 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 Multiple oral dose of alcohol
Active Comparator: Energy drink 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 Multiple oral dose of energy drink
Placebo Comparator: Placebo 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 Multiple oral dose of water Multiple oral dose of non-caffeinated soft drink Other Names: Non-active treatment

Outcome Measures

Primary Outcome Measures

Change in tracking test performance [From baseline till 4 hours after administration]
The total time outside the road will be measured in the tracking test

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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