Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
32 participants
INTERVENTIONAL
2020-10-08
2021-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Alcohol and Energy Drink (AmED)
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
Alcohol and Energy Drink (AmED)
Multiple oral dose of alcohol mixed with ED
Alcohol and Energy drink Placebo
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)
Alcohol and Energy drink Placebo
Multiple oral dose of alcohol mixed with ED placebo (soft drink)
Alcohol placebo and Energy drink
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
Alcohol placebo and Energy drink
Multiple oral dose of alcohol placebo (water) mixed with ED
Alcohol placebo and Energy drink placebo
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
Alcohol placebo and energy drink placebo
Multiple oral dose of alcohol placebo (water) mixed with ED placebo (soft drink)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
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.
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.
18 Years
40 Years
ALL
Yes
Sponsors
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Germans Trias i Pujol Hospital
OTHER
Fundació Institut Germans Trias i Pujol
OTHER
Responsible Party
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Principal Investigators
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Clara Pérez-Mañá, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitari Germans Trias i Pujol-IGTP
Locations
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Hospital Universitari Germans Trias i Pujol-Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol (IGTP)
Badalona, Barcelona, Spain
Countries
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Central Contacts
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Facility Contacts
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Clara Pérez-Mañá, MD, PhD
Role: primary
Magi Farré, MD,PhD
Role: backup
References
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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.
Other Identifiers
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HUGTP/ENERGYBINGE/PNSD/1
Identifier Type: OTHER
Identifier Source: secondary_id
HUGTP/ENERGYBINGE/PNSD/1
Identifier Type: -
Identifier Source: org_study_id