Interaction of Alcohol With Energy Drinks

Alcohol-Related Disorders Clinical Trial

— AEDED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02771587
• Other study ID #: IMIMFTCL/AEDED
• Status: Completed
• Phase: Phase 1
• First received: May 10, 2016
• Last updated: October 18, 2016
• Start date: June 2016
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Alcohol-Related Disorders
• Drinking and Driving

Intervention

Dietary Supplement:
• Alcohol and energy drink
Multiple oral dose of alcohol Multiple oral dose of energy drink
• Alcohol
Multiple oral dose of alcohol
• Energy drink
Multiple oral dose of energy drink
• Placebo
Multiple oral dose of water Multiple oral dose of non-caffeinated soft drink

Locations

Country	Name	City	State
Spain	IMIM	Barcelona
Spain	Parc de Salut Mar-IMIM	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Change in drunkenness	Drunkenness will be measured using a visual analog scale (0-100 mm)	From baseline till 8 hours after administration	No
Secondary	Change in drowsiness	Drowsiness will be measured using a visual analog scale (0-100 mm)	From baseline till 8 hours after administration	No
Secondary	Change in headache	Headache will be measured using a visual analog scale (0-100 mm)	From baseline till 8 hours after administration	No
Secondary	Change in palpitations	Palpitations will be measured using a visual analog scale (0-100 mm)	From baseline till 8 hours after administration	No
Secondary	Change in anxiety	Anxiety will be measured using a visual analog scale (0-100 mm)	From baseline till 8 hours after administration	No
Secondary	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	No
Secondary	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	No
Secondary	Change in blood pressure	Systolic and diastolic blood pressure will be measured	From baseline till 8 hours after administration	No
Secondary	Change in heart rate	Heart rate will be measured	From baseline till 8 hours after administration	No
Secondary	Change in oral temperature	Oral temperature will be measured	From baseline till 8 hours after administration	No
Secondary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Maximum concentration (Cmax) of taurine		From baseline till 8 hours after administration	No
Secondary	Maximum concentration (Cmax) of ethanol		From baseline till 8 hours after administration	No
Secondary	Maximum concentration (Cmax) of caffeine		From baseline till 8 hours after administration	No
Secondary	Time to reach maximum concentration (tmax) of ethanol		From baseline till 8 hours after administration	No
Secondary	Time to reach maximum concentration (tmax) of caffeine		From baseline till 8 hours after administration	No
Secondary	Time to reach maximum concentration (tmax) of taurine		From baseline till 8 hours after administration	No
Secondary	Blood coagulation prothrombin	Prothrombin time (PT) and ratio will be measured	From baseline till 2 hours after administration	No
Secondary	Blood coagulation thromboplastin	Activated partial thromboplastin time (APTT) and ratio will be measured	From baseline till 2 hours after administration	No
Secondary	Platelet aggregation (function)	Platelet function (PFA) will be measured	From baseline till 2 hours after administration	No
Secondary	Platelet count	Platelet count will be measured	From baseline till 2 hours after administration	No
Secondary	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	No
Secondary	Like the drug (drink)	Drug liking will be measured using a visual analog scale (0-100 mm)	At the end of each experimental session	No