Clinical trial NCT02771587: Interaction of Alcohol With Energy Drinks
Official title: Effects of Alcohol and Energy Drinks on Driving Performance and Bleeding Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alcohol-Related Disorders
Drinking and Driving
Keywords: alcohol
energy drink
coagulability
caffeine
taurine
driving performance
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2016-05-13
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in tracking test performance
timeFrame: From baseline till 4 hours after administration
Secondary outcomes:
measure: Change in simple reaction time (SRT)
timeFrame: From baseline till 4 hours after administration
measure: Change in movement estimation
timeFrame: From baseline till 4 hours after administration
measure: Change in memory function
timeFrame: From baseline till 4 hours after administration
measure: Change in drunkenness
timeFrame: From baseline till 8 hours after administration
measure: Change in drowsiness
timeFrame: From baseline till 8 hours after administration
measure: Change in headache
timeFrame: From baseline till 8 hours after administration
measure: Change in palpitations
timeFrame: From baseline till 8 hours after administration
measure: Change in anxiety
timeFrame: From baseline till 8 hours after administration
measure: Change in subjective effects measured with Addiction Research Center Inventory (ARCI)
timeFrame: From baseline till 8 hours after administration
measure: Change in subjective effects measured with Biphasic alcohol effects scale (BAES)
timeFrame: From baseline till 8 hours after administration
measure: Change in blood pressure
timeFrame: From baseline till 8 hours after administration
measure: Change in heart rate
timeFrame: From baseline till 8 hours after administration
measure: Change in oral temperature
timeFrame: From baseline till 8 hours after administration
measure: Number of participants with serious and non-serious adverse events
timeFrame: From inclusion till one week after the last experimental session
measure: Area under the concentration-time curve (AUC 0-8h) of ethanol blood concentrations
timeFrame: From baseline till 8 hours after administration
measure: Area under the concentration-time curve (AUC 0-8h) of taurine blood concentrations
timeFrame: From baseline till 8 hours after administration
measure: Area under the concentration-time curve (AUC 0-8h) of caffeine blood concentrations
timeFrame: From baseline till 8 hours after administration
measure: Area under the concentration-time curve (AUC 0-8h) of ethanol breath air concentrations
timeFrame: From baseline till 8 hours after administration
measure: Maximum concentration (Cmax) of taurine
timeFrame: From baseline till 8 hours after administration
measure: Maximum concentration (Cmax) of ethanol
timeFrame: From baseline till 8 hours after administration
measure: Maximum concentration (Cmax) of caffeine
timeFrame: From baseline till 8 hours after administration
measure: Time to reach maximum concentration (tmax) of ethanol
timeFrame: From baseline till 8 hours after administration
measure: Time to reach maximum concentration (tmax) of caffeine
timeFrame: From baseline till 8 hours after administration
measure: Time to reach maximum concentration (tmax) of taurine
timeFrame: From baseline till 8 hours after administration
measure: Blood coagulation prothrombin
timeFrame: From baseline till 2 hours after administration
measure: Blood coagulation thromboplastin
timeFrame: From baseline till 2 hours after administration
measure: Platelet aggregation (function)
timeFrame: From baseline till 2 hours after administration
measure: Platelet count
timeFrame: From baseline till 2 hours after administration
measure: Change in willingness to drive
timeFrame: From baseline till 6 hours after administration
measure: Like the drug (drink)
timeFrame: At the end of each experimental session
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: IMIM
city: Barcelona
country: Spain
facility: Parc de Salut Mar-IMIM
Study officials:
affiliation: IMIM
name: Clara Pérez Mañá, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.