Interaction of Alcohol With Energy Drinks (AEDED)

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

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.

Study Overview

• Status: Completed
• Conditions: Alcohol-Related Disorders; Drinking and Driving
• Intervention / Treatment: Dietary supplement: Alcohol and energy drink; Dietary supplement: Alcohol; Dietary supplement: Energy drink; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08003
    • IMIM
  • Barcelona, Spain, 08003
    • Parc de Salut Mar-IMIM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Parc de Salut Mar
• Investigators: Principal Investigator: Clara Pérez Mañá, PhD, MD, IMIM

Publications and helpful links

General Publications

• Perez-Mana C, Mateus JA, Diaz-Pellicer P, Diaz-Baggerman A, Perez M, Pujadas M, Fonseca F, Papaseit E, Pujol J, Langohr K, de la Torre R. Effects of Mixing Energy Drinks With Alcohol on Driving-Related Skills. Int J Neuropsychopharmacol. 2022 Jan 12;25(1):13-25. doi: 10.1093/ijnp/pyab051.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: May 10, 2016
• First Submitted That Met QC Criteria: May 10, 2016
• First Posted (Estimate): May 13, 2016

Study Record Updates

• Last Update Posted (Estimate): October 19, 2016
• Last Update Submitted That Met QC Criteria: October 18, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: alcohol; caffeine; taurine; energy drink; driving performance; coagulability
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Alcohol-Related Disorders; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Ethanol
• Other Study ID Numbers: IMIMFTCL/AEDED

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No