Binge Drinking of Alcohol Mixed With Energy Drinks
ENERGYBINGE
Combination of Alcohol and Energy Drinks in a Binge Drinking Pattern: Acute Effects and Gender Differences
1 other identifier
interventional
32
1 country
1
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Oct 2020
Typical duration for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 8, 2020
CompletedFirst Submitted
Initial submission to the registry
October 30, 2020
CompletedFirst Posted
Study publicly available on registry
November 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedNovember 9, 2020
November 1, 2020
1.1 years
October 30, 2020
November 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (26)
Area under the concentration-time curve (AUC 0-8h) of ethanol blood concentrations
From baseline to 8 hours after administration
Area under the concentration-time curve (AUC 0-8h) of ethanol breath concentrations
From baseline to 8 hours after administration
Area under the concentration-time curve (AUC 0-8h) of caffeine blood concentrations
From baseline to 8 hours after administration
Maximum concentration (Cmax) of ethanol in blood
From baseline to 8 hours after administration
Maximum concentration (Cmax) of caffeine in plasma
From baseline to 8 hours after administration
- +21 more secondary outcomes
Study Arms (4)
Alcohol and Energy Drink (AmED)
EXPERIMENTALThe 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
Alcohol and Energy drink Placebo
ACTIVE COMPARATORThe 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)
Alcohol placebo and Energy drink
ACTIVE COMPARATORThe 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
Alcohol placebo and Energy drink placebo
PLACEBO COMPARATORThe 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
Interventions
Multiple oral dose of alcohol mixed with ED
Multiple oral dose of alcohol mixed with ED placebo (soft drink)
Multiple oral dose of alcohol placebo (water) mixed with ED
Multiple oral dose of alcohol placebo (water) mixed with ED placebo (soft drink)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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.
- Smokers of \>5 cigarettes/day
- Consumption of \>20 g/day of alcohol (females) or of \>40 g/day (males)
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitari Germans Trias i Pujol-Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol (IGTP)
Badalona, Barcelona, 08916, Spain
Related Publications (1)
Hladun O, Papaseit E, Poyatos L, Martin S, Perez-Acevedo AP, Barriocanal AM, Bustos-Cardona T, Malumbres S, De La Torre R, Langohr K, Farre M, Perez-Mana C. No significant gender differences in driving-related skills following alcohol mixed with energy drinks during an experimental binge-drinking episode. Front Pharmacol. 2025 May 23;16:1581229. doi: 10.3389/fphar.2025.1581229. eCollection 2025.
PMID: 40487410DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Clara Pérez-Mañá, MD, PhD
Hospital Universitari Germans Trias i Pujol-IGTP
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double-blind
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2020
First Posted
November 5, 2020
Study Start
October 8, 2020
Primary Completion
December 1, 2021
Study Completion
December 1, 2021
Last Updated
November 9, 2020
Record last verified: 2020-11