Binge Drinking of Alcohol Mixed With Energy Drinks

Healthy Clinical Trial

— ENERGYBINGE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04616859
• Other study ID #: HUGTP/ENERGYBINGE/PNSD/1
• Secondary ID: HUGTP/ENERGYBING
• Status: Recruiting
• Phase: N/A
• Start date: October 8, 2020
• Est. completion date: December 2021

Study information

• Verified date: November 2020
• Source: Fundació Institut Germans Trias i Pujol
• Contact: Clara Pérez-Mañá, MD,PhD
• Phone: +34 93 497 88 65
• Email: cperezm.mn.ics[@]gencat.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. 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.

2. 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

3. 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.

4. Understand and accept the study's procedures and sign an informed consent form.

5. No evidence of somatic or psychiatric disorders as per past medical history and physical examination.

6. 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:

1. Not fill the inclusion criteria.

2. 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.

3. 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.

4. Previous or actual psychiatric disorders, alcoholism, abuse of prescription drugs or illegal substances or regular consumption of psychoactive drugs.

5. 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

6. Having had any somatic disease or having undergone major surgery in the 3 months prior to inclusion in the trial.

7. 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.

8. 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.

9. Smokers of >5 cigarettes/day

10. Consumption of >20 g/day of alcohol (females) or of >40 g/day (males)

11. 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.

12. Subjects unable to understand the nature, consequences of the study and the procedures requested to be followed.

13. Subjects with positive serology to Hepatitis B, C or HIV.

14. Pregnant, breastfeeding women and those using hormonal contraception,. Those not using an effective contraceptive (i.e. abstinence, intrauterine devices, barrier methods or partner vasectomy).

15. Women with amenorrhea or suffering severe premenstrual syndrome.

Related Conditions & MeSH terms

• Alcohol Drinking
• Binge Drinking
• Healthy

Intervention

Dietary Supplement:
• Alcohol and Energy Drink (AmED)
Multiple oral dose of alcohol mixed with ED
• Alcohol and Energy drink Placebo
Multiple oral dose of alcohol mixed with ED placebo (soft drink)
• Alcohol placebo and Energy drink
Multiple oral dose of alcohol placebo (water) mixed with ED
• Alcohol placebo and energy drink placebo
Multiple oral dose of alcohol placebo (water) mixed with ED placebo (soft drink)

Locations

Country	Name	City	State
Spain	Hospital Universitari Germans Trias i Pujol-Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol (IGTP)	Badalona	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Fundació Institut Germans Trias i Pujol	Germans Trias i Pujol Hospital

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Maximum concentration (Cmax) of ethanol in blood	Maximum concentration (Cmax) of ethanol in blood	From baseline to 8 hours after administration
Secondary	Maximum concentration (Cmax) of caffeine in plasma	Maximum concentration (Cmax) of caffeine in plasma	From baseline to 8 hours after administration
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Maximum concentration (Cmax) of taurine plasma concentrations	Maximum concentration (Cmax) of taurine plasma concentrations	From baseline to 8 hours after administration
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Beverage identification	Beverage identification questionnaire.There is an option to select each treatment condition. Only measured at 8h after administration	8 hours after administration
Secondary	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