Binge Drinking of Alcohol Mixed With Energy Drinks

Study Overview
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Brief Summary
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The purpose of the study is to assess the relevance of gender in the acute effects (subjective, physiological and driving-related skills) observed after controlled administration of alcohol in a binge-drinking pattern mixed with energy drinks (AmED)

Detailed Description
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Consumption of alcohol mixed with energy drinks (AmED) has increased mainly among young people. Energy drinks (ED) are usually combined with alcohol with the intention of counteracting its effects. However, most studies have not shown a reduction in drunkenness and consumption is related with engagement of risk-taking behaviours like driving under alcohol effects. It is already known that alcohol concentrations and effects are higher in women than in men even after adjusting dose by weight. The relevance of gender in the acute effects of alcohol associated with ED consumed in a binge-drinking pattern has been poorly studied. A randomized clinical trial will be conducted in healthy volunteers (1:1) and four treatment conditions will be administered: alcohol+ED, alcohol+placebo of ED, placebo of alcohol+ED and placebo of alcohol+placebo of ED. Subjective and physiological effects, driving related skills, and alcohol and caffeine concentrations will be measured along an 8-hours period. A pilot study has been conducted with the first 6 volunteers to select the alcohol doses. In the definitive study 70 g of alcohol in men and 55 g in women will be used.

Official Title
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Combination of Alcohol and Energy Drinks in a Binge Drinking Pattern: Acute Effects and Gender Differences

Conditions
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Healthy, Alcohol Drinking

Intervention / Treatment
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* Dietary Supplement: Alcohol and Energy Drink (AmED)
* Dietary Supplement: Alcohol and Energy drink Placebo
* Dietary Supplement: Alcohol placebo and Energy drink
* Dietary Supplement: Alcohol placebo and energy drink placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females between 18-40 years old, weight between 50 and 100 kg and BMI (BMI=weight/height²) between 20-28 kg/m². Lower or higher BMIs will be allowed, if the researchers considered that do not suppose a risk to the subjects and do not interfere with the objectives of the study. Recreational alcohol consumption in form of occasional binge-drinking (≥1 episode / month) and at least consumption of 1 unit (10 g, standard drink - one alcoholic drink equivalent) per day or its equivalent over the whole week [7 units, 70 g)]) and having experienced drunkenness several times Regular consumption of beverages containing methylxanthines at least 7 per week (coffee, tea, chocolate, cola soda, energy drinks). Consumption of energy drinks at least once. 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. The ECG and general blood and urine laboratory tests performed before the study should be within normal ranges. Minor or occasional changes from normal ranges are accepted if, in the investigator's opinion, considering the current state of the art, they are not clinically significant, are not life-threatening for the subjects and do not interfere with the product assessment. These changes and their non-relevance will be justified in writing specifically. Exclusion Criteria: Not fill the inclusion criteria. Pathological history or evidence of a preexisting condition (including gastrointestinal, liver, or kidney disorders) that may alter the absorption, distribution, metabolism or excretion of drugs or symptoms suggestive of drug-induced gastrointestinal irritation. Present history of a substance use disorder according to Diagnostic and Statistical Manual for Mental Disorders (DSM-V), except for nicotine. Past history of mild substance use disorder (corresponding to substance abuse according to DSM-IV) could be included. Previous or actual 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. Asian subjects with no intolerance or no serious adverse reactions to alcohol could be included. 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. Subjects unable to understand the nature, consequences of the study and the procedures requested to be followed. Subjects with positive serology to Hepatitis B, C or HIV. Pregnant, breastfeeding women and those using hormonal contraception,. Those not using an effective contraceptive (i.e. abstinence, intrauterine devices, barrier methods or partner vasectomy). Women with amenorrhea or suffering severe premenstrual syndrome.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alcohol and Energy Drink (AmED)<br>The total volume of drink will be 761 ml in women and 969 ml in men. The doses will be divided into 6 fractions administered one every 15 min simulating a binge drinking pattern (80 min in total). Women: Ethanol 172 ml (55 g) + ED 589 ml Men: Ethanol 219 ml (70 g) + ED 750 ml | Dietary Supplement: Alcohol and Energy Drink (AmED)<br>* Multiple oral dose of alcohol mixed with ED<br>|
| Active Comparator: Alcohol and Energy drink Placebo<br>The total volume of drink will be 761 ml in women and 969 ml in men. The doses will be divided into 6 fractions administered one every 15 min simulating a binge drinking pattern (80 min in total). Women: Ethanol 172 mL (55 g) + placebo ED (a non-caffeinated soft drink) 589 mL Men: Ethanol 219 mL(70 g) + placebo ED 750 mL (a non-caffeinated soft drink) | Dietary Supplement: Alcohol and Energy drink Placebo<br>* Multiple oral dose of alcohol mixed with ED placebo (soft drink)<br>|
| Active Comparator: Alcohol placebo and Energy drink<br>The total volume of drink will be 761 ml in women and 969 ml in men. The doses will be divided into 6 fractions administered one every 15 min simulating a binge drinking pattern (80 min in total). Women: Ethanol placebo (water) 172 mL + ED 589 mL Men: Ethanol placebo (water) 219 mL + ED 750 mL | Dietary Supplement: Alcohol placebo and Energy drink<br>* Multiple oral dose of alcohol placebo (water) mixed with ED<br>|
| Placebo Comparator: Alcohol placebo and Energy drink placebo<br>The total volume of drink will be 761 ml in women and 969 ml in men. The doses will be divided into 6 fractions administered one every 15 min simulating a binge drinking pattern (80 min in total). Women: Ethanol placebo (water) 172 mL+ placebo ED (a non-caffeinated soft drink) 589 mL Men: Ethanol placebo (water) 219 mL + placebo ED (a non-caffeinated soft drinks) 750 mL | Dietary Supplement: Alcohol placebo and energy drink placebo<br>* Multiple oral dose of alcohol placebo (water) mixed with ED placebo (soft drink)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in subjective effects measured with Biphasic alcohol effects scale (BAES) | Subjective effects of alcohol will be measured using Biphasic alcohol effects scale (0-70 points). Higher scores mean worse outcome. Obtained baseline and 1, 1.30, 2, 3, 4, 6 and 8-h after administration. | From baseline to 8 hours after administration | 
| Change in psychomotor vigilance task (PVT) | Test will be performed using a specific software. Mean latency will be measured. Obtained baseline and 1.30, 4 and 6-h after administration. | From baseline to 6 hours after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration-time curve (AUC 0-8h) of ethanol blood concentrations | Calculation of AUC of ethanol blood concentrations. Obtained baseline and 0.30h , 1, 1.30, 2, 2.30, 3, 4, 6 and 8-h after administration. | From baseline to 8 hours after administration | 
| Area under the concentration-time curve (AUC 0-8h) of ethanol breath concentrations | Obtained baseline and 0.15, 0.30 , 0.45, 1, 1.15,1.30, 1.45, 2, 2.15, 2.30, 3, 4, 6 and 8-h after administration. | From baseline to 8 hours after administration | 
| Area under the concentration-time curve (AUC 0-8h) of caffeine blood concentrations | Calculation of AUC of caffeine concentrations obtained baseline and 0.30, 1, 1.30, 2, 2.30, 3, 4, 6 and 8-h after administration. | From baseline to 8 hours after administration | 
| Maximum concentration (Cmax) of ethanol in blood | Maximum concentration (Cmax) of ethanol in blood | From baseline to 8 hours after administration | 
| Maximum concentration (Cmax) of caffeine in plasma | Maximum concentration (Cmax) of caffeine in plasma | From baseline to 8 hours after administration | 
| Time to reach maximum concentration (tmax) of ethanol in blood | Time to reach maximum concentration (tmax) of ethanol in blood | From baseline to 8 hours after administration | 
| Time to reach maximum concentration (tmax) of ethanol in breath air | Time to reach maximum concentration (tmax) of ethanol in breath air | From baseline to 8 hours after administration | 
| Time to reach maximum concentration (tmax) of caffeine in plasma | Time to reach maximum concentration (tmax) of caffeine in plasma | From baseline to 8 hours after administration | 
| Area under the concentration-time curve (AUC 0-8h) of taurine plasma concentrations | Calculation of AUC of taurine concentrations obtained baseline and 0.30h , 1, 1.30, 2, 2.30, 3, 4, 6 and 8-h after administration | From baseline to 8 hours after administration | 
| Maximum concentration (Cmax) of taurine plasma concentrations | Maximum concentration (Cmax) of taurine plasma concentrations | From baseline to 8 hours after administration | 
| Time to reach maximum concentration (tmax) of taurine plasma concentrations | Time to reach maximum concentration (tmax) of taurine plasma concentrations | From baseline to 8 hours after administration | 
| Change in drunkenness feeling | Drunkenness will be measured using a visual analog scale (0-100 mm). Higher scores mean worse outcome. Obtained baseline and 0.30, 1, 1.30, 2, 2.30, 3, 4, 6 and 8-h after administration. | From baseline to 8 hours after administration | 
| Change in dizziness feeling | Dizziness will be measured using a visual analog scale (0-100 mm).Higher scores mean worse outcome. Obtained baseline and 0.30, 1, 1.30, 2, 2.30, 3, 4, 6 and 8-h after administration. | From baseline to 8 hours after administration | 
| Change in drowsiness feeling | Drowsiness will be measured using a visual analog scale (0-100 mm). Higher scores mean worse outcome. Obtained baseline and 0.30, 1, 1.30, 2, 2.30, 3, 4, 6 and 8-h after administration. | From baseline to 8 hours after administration | 
| Change in palpitations reported by the participant | Palpitations will be measured using a visual analog scale (0-100 mm). Higher scores mean worse outcome. Obtained baseline and 0.30, 1, 1.30, 2, 2.30, 3, 4, 6 and 8-h after administration. | From baseline to 8 hours after administration | 
| Change in anxiety feeling | Anxiety will be measured using a visual analog scale (0-100 mm).Higher scores mean worse outcome. Obtained baseline and 0.30, 1, 1.30, 2, 2.30, 3, 4, 6 and 8-h after administration. | From baseline to 8 hours after administration | 
| Change in headache | Headache will be measured using a visual analog scale (0-100 mm). Higher scores mean worse outcome. Obtained baseline and 0.30, 1, 1.30, 2, 2.30, 3, 4, 6 and 8-h after administration. | From baseline to 8 hours after administration | 
| Change in ability and predisposition to drive in certain situations | Will be measured using a visual analog scale (0-100 mm).Higher scores mean worse outcome. Obtained baseline and 1.30, 4, 6 and 8-h after administration. | From baseline to 8 hours after administration | 
| Desire to keep drinking | Will be measured using a visual analog scale (0-100 mm). Higher scores mean worse outcome. Obtained at the end of beverage administration. Only one measure at 1.30 hours. | At 1.30 hours | 
| Change in subjective effects measured with Addiction Research Center Inventory (ARCI) | Obtained baseline and 1, 1.45, 4, 6 and 8-h after administration. | From baseline to 8 hours after administration | 
| Change in blood pressure | Systolic and diastolic blood pressure (mmHg) will be measured obtained baseline and 0.30, 1, 1.30, 2, 2.30, 3, 4, 6 and 8-h after administration. | From baseline to 8 hours after administration | 
| Change in heart rate | Heart rate (beats/min) will be measured obtained baseline and 0.30, 1, 1.30, 2, 2.30, 3, 4, 6 and 8-h after administration. | From baseline to 8 hours after administration | 
| Change in oral temperature | Oral temperature (ºC) will be measured obtained baseline and 0.30, 1, 1.30, 2, 2.30, 3, 4, 6 and 8-h after administration. | From baseline to 8 hours after administration | 
| Change in Maddox Wing score (MW) | Maddox wing is a device for the measurement of diopters of horizontal heterophoria. From 22 (exophoria) to 15 (esophoria). Higher scores mean worse outcome.Obtained baseline and 1.30, 4 and 6-h after administration. | From baseline to 6 hours after administration | 
| Beverage identification | Beverage identification questionnaire.There is an option to select each treatment condition. Only measured at 8h after administration | 8 hours after administration | 
| Change in tracking test performance | Test will be performed using a computer program. Total time outside the road and number of errors will be measured. Obtained baseline and 1.30, 4 and 6-h after administration. | From baseline to 6 hours after administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alcohol binge drinking, alcohol, energy drinks, pharmacokinetics, caffeine, gender