- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07588022
Acute Effects of Jägermeister With Energy Drinks (Jägermbomb) (JB)
Acute Effects of an Explosive Cocktail With Energy Drinks That is Trendy Among Young People, the Jägerbomb
Study Overview
Status
Detailed Description
Alcohol use is very common among young people in Spain. Binge drinking is a pattern of alcohol consumption that raises blood alcohol concentration (BAC) to 0.08% or higher (0.4 mg/L in breath air), typically defined as drinking 5 or more standard drinks for men or 4 or more for women within about 2 hours.This is a serious public health problem because it can cause illness, injuries, and even death.
Energy drinks (ED) are also widely used by young people and are often mixed with alcohol. People do this to hide the taste of alcohol or to feel less tired or drunk. However, ED do not reduce alcohol intoxication and are linked to more risky behavior. Research suggests that ED only slightly reduce some alcohol-related problems, such as slower reactions. This can give a false feeling of safety and make people more likely to drive while drunk.
One popular mixture is the Jägerbomb, a combination of Jägermeister liquor and energy drink (ED), but its effects have not been previously studied.
This study will be conducted as a randomized, double-blind, placebo-controlled trial in healthy adults who have experience consuming alcohol and caffeinated beverages.
A pilot study has been conducted in the first four participants (two women and two men) using a dose of 55 g of alcohol.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Clara Pérez-Mañá, MD, PhD
- Phone Number: +34934978865
- Email: cperezm.mn.ics@gencat.cat
Study Contact Backup
- Name: Soraya Martín
- Phone Number: +34934973831
- Email: smartins.mn.ics@gencat.cat
Study Locations
-
-
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Barcelona, Spain
- Recruiting
- Hospital Universitari Germans Trias i Pujol-IGTP
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Principal Investigator:
- Clara Pérez-Mañá, MD, PhD
-
Contact:
- Soraya Martín Sánchez, Mrs
- Phone Number: +34934973831
- Email: smartins.mn.ics@gencat.cat
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Men and women between 18-45 years old with a weight between 50-90 kg for men and between 55-80 kg for women, and a body mass index (BMI) between 19-28 kg/m2. Lower or higher weights or BMIs are allowed, in the opinion of the Principal Investigator or the collaborators designated by the Principal Investigator and that do not pose a risk to the subjects and do not interfere with the objectives of the study.
- Alcohol consumption in the form of occasional binge drinking (≥1 time/month), social alcohol consumption (≥10g/day distributed weekly) and experience in alcohol intoxication.
- Consumption ≥7 drinks with methylxanthines (coffee, tea, chocolate, cola, BE) per week and who have consumed ED on at least one occasion.
- Understand and agree to the trial procedures and sign an informed consent.
- History and physical examination that demonstrate no organic or psychiatric disorders.
- The ECG and general blood and urine tests performed before the test should be within normal limits. Minor or punctual variations from the limits of normality are allowed if, at the discretion of the Principal Investigator, taking into account the state of science, they are not of clinical significance, do not pose a risk to the subjects and do not interfere with the assessment of the product. These variations and their non-relevance will be justified in writing in a specific way.
Exclusion Criteria:
- Not meeting the inclusion criteria.
- History or clinical evidence of gastrointestinal, liver, renal or other disorders that may involve an alteration in the absorption, distribution, metabolism or excretion of the drug, or that are suggestive of gastrointestinal irritation by drugs.
- Current history of substance use disorder according to DSM-V (except nicotine). A previous history of mild substance use disorder (corresponding to substance abuse according to DSM-IV criteria) is admitted.
- History or clinical evidence of psychiatric disorders, alcoholism, abuse of drugs or other drugs or habitual consumption of psychoactive drugs.
- Have participated in clinical trials with drugs or nutraceuticals in the previous 12 weeks.
5) Have suffered any organic disease or major surgery in the three months prior to the start of the study.
6) Subjects who have an intolerance or have had serious adverse reactions to alcohol. The inclusion of subjects of oriental origin who do not have an intolerance to alcohol will be allowed.
7) Have taken medication regularly in the month prior to the study sessions, with the exception of vitamins, herbal remedies, or dietary supplements that, in the judgment of the Principal Investigator or collaborators designated by the Principal Investigator, do not pose a risk to the subjects and do not interfere with the objectives of the study. Treatment with single doses of symptomatic medication in the week prior to study sessions will not be grounds for exclusion if it is assumed to have been completely eliminated on the day of the experimental session.
8) Smokers of >5 cigarettes a day. 9) Consumption of more than 20 g of alcohol daily in women and more than 40 g in men.
10) Consumers of more than 5 coffees, teas, colas, or other stimulant or xanthine beverages daily in the 3 months prior to the start of the study.
11) Subjects who are not able to understand the nature of the trial and the procedures they are asked to follow.
12) Subjects with positive serology for hepatitis B, C or HIV. 13) Women who are pregnant or breastfeeding, or who use hormonal contraceptives or do not use reliable contraceptive measures during the study (such as abstinence, intrauterine devices, barrier methods or with a vasectomized partner).
14) Women with amenorrhea or premenstrual syndrome of severe intensity.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Alcohol (Jägermeister) and Energy Drink: Jägerbomb
The total volume of drink is 821 mL in women and 875 mL in men, and is divided into 5 doses simulating a binge pattern, administered every 10 min (total time 45 minutes).
Women: Jägermeister 196 mL (ethanol 55 g) + ED 625 ml (200 mg caffeine).
Men: Jägermeister 250 mL (ethanol 70 g) + ED 625 ml (200 mg caffeine)
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Multiple oral dose of Jägermeister mixed with ED
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Active Comparator: Alcohol (Jägermeister) and Energy Drink Placebo
The total volume of drink is 821 mL in women and 875 mL in men, and is divided into 5 doses simulating a binge pattern, administered every 10 min (total time 45 minutes).
Women: Jägermeister 196 mL (55 g of ethanol) + placebo ED (a non-caffeinated soft drink) 625 mL.
Men: Jägermeister 250 mL (70 g) + placebo ED (a non-caffeinated soft drink) 625 mL.
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Multiple oral dose of Jägermeister mixed with a placebo of ED (non-caffeinated soft drink)
|
|
Placebo Comparator: Alcohol placebo and Energy Drink Placebo
The total volume of drink is 821 mL in women and 875 mL in men, and is divided into 5 doses simulating a binge pattern, administered every 10 min (total time 45 minutes).
Women: Ethanol placebo (water) + ED placebo (a non-caffeinated soft drink) 625 mL.
Men: Ethanol placebo (water) + ED placebo (a non-caffeinated soft drink) 625 mL.
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Multiple oral dose of alcohol placebo (water) mixed with ED placebo (non-caffeinated soft drink)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in reaction time (Psychomotor Vigilance Task)
Time Frame: From baseline to 4 hours after administration
|
Test will be performed using a computer program.
Mean and median latency will be assessed.
Obtained baseline, 1.5 and 4-h after administration.
|
From baseline to 4 hours after administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to reach maximum concentration (tmax) of ethanol in breath air
Time Frame: From baseline to 8 hours after administration
|
Time to reach maximum concentration (tmax) of ethanol in breath air
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From baseline to 8 hours after administration
|
|
Maximum concentration (Cmax) of ethanol in breath air
Time Frame: From baseline to 8 hours after administration
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Maximum concentration (Cmax) of ethanol in breath air
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From baseline to 8 hours after administration
|
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Maximum concentration (Cmax) of caffeine in oral fluid
Time Frame: From baseline to 6 hours after administration
|
Maximum concentration (Cmax) of caffeine in oral fluid
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From baseline to 6 hours after administration
|
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Area under the concentration-time curve (AUC 0-8h) of ethanol breath concentrations
Time Frame: From baseline to 8 hours after administration
|
Obtained baseline and 0.17, 0.33 , 0.5, 0.66, 0,83, 1, 1.25, 1.5, 2, 3, 4, 6 and 8-h after administration.
|
From baseline to 8 hours after administration
|
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Area under the concentration-time curve (AUC 0-6h) of caffeine oral fluid concentrations
Time Frame: From baseline to 6 hours after administration
|
Calculation of AUC of caffeine concentrations obtained baseline and 1, 1.5, 2, 4, 6-h after administration.
|
From baseline to 6 hours after administration
|
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Time to reach maximum concentration (tmax) of caffeine in oral fluid
Time Frame: From baseline to 6 hours after administration
|
Time to reach maximum concentration (tmax) of caffeine in oral fluid
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From baseline to 6 hours after administration
|
|
Maximum concentration (Cmax) of cortisol in oral fluid
Time Frame: From baseline till 6 hours after administration
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Maximum concentration (Cmax) of cortisol in oral fluid
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From baseline till 6 hours after administration
|
|
Time to reach maximum concentration (tmax) of saliva in oral fluid
Time Frame: From baseline to 6 hours after administration
|
Time to reach maximum concentration (tmax) of saliva in oral fluid
|
From baseline to 6 hours after administration
|
|
Area under the concentration-time curve (AUC 0-6h) of cortisol concentrations in oral fluid
Time Frame: From baseline till 6 hours after administration
|
Calculation of AUC of cortisol oral fluid concentrations.
Obtained baseline and 1, 1.5 , 2, 4, 6-h after administration.
|
From baseline till 6 hours after administration
|
|
Change in visual acuity
Time Frame: From baseline to 4 hours after administration
|
A computer program will be used to measure static and dynamic visual acuity with different contrast (100% and 10%) at baseline, 2 and 4-h after administration
|
From baseline to 4 hours after administration
|
|
Change in unstable tracking task
Time Frame: From baseline to 4 hours after administration
|
Test will be performed using a computer program.
Mean lambda and number of errors will be measured.
Obtained baseline and 1.5, 4-h after administration.
|
From baseline to 4 hours after administration
|
|
Change in pupillary diameter
Time Frame: From baseline to 4 hours after administration
|
Pupillary diameter will be measured with a manual pupilometer
|
From baseline to 4 hours after administration
|
|
Change in drowsiness feeling
Time Frame: From baseline to 8 hours after administration
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Drowsiness will be measured using a visual analog scale (0-100 mm).
Higher scores mean worse outcome.
Obtained baseline and 0.5, 1, 1.5, 2, 3, 4, 6 and 8-h after administration.
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From baseline to 8 hours after administration
|
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Change in drunkenness feeling
Time Frame: From baseline to 8 hours after administration
|
Drunkenness will be measured using a visual analog scale (0-100 mm).
Higher scores mean worse outcome.
Obtained baseline and 0.5, 1, 1.5, 2, 3, 4, 6 and 8-h after administration
|
From baseline to 8 hours after administration
|
|
Change in dizziness feeling
Time Frame: From baseline to 8 hours after administration
|
Dizziness will be measured using a visual analog scale (0-100 mm).
Higher scores mean worse outcome.
Obtained baseline and 0.5, 1, 1.5, 2, 3, 4, 6 and 8-h after administration
|
From baseline to 8 hours after administration
|
|
Change in palpitations reported by the participant
Time Frame: From baseline to 8 hours after administration
|
Palpitations will be measured using a visual analog scale (0-100 mm).
Higher scores mean worse outcome.
Obtained baseline and 0.5, 1, 1.5, 2, 3, 4, 6 and 8-h after administration.
|
From baseline to 8 hours after administration
|
|
Change in anxiety feeling
Time Frame: From baseline to 8 hours after administration
|
Anxiety will be measured using a visual analog scale (0-100 mm).
Higher scores mean worse outcome.
Obtained baseline and 0.5, 1, 1.5, 2, 3, 4, 6 and 8-h after administration.
|
From baseline to 8 hours after administration
|
|
Change in headache
Time Frame: From baseline to 8 hours after administration
|
Headache will be measured using a visual analog scale (0-100 mm).
Higher scores mean worse outcome.
Obtained baseline and 0.5, 1, 1.5, 2, 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
Time Frame: From baseline to 6 hours after administration
|
Will be measured using a visual analog scale (0-100 mm).Higher scores mean worse outcome.
Obtained baseline and 1.5, 4, 6-h after administration.
|
From baseline to 6 hours after administration
|
|
Desire to keep drinking
Time Frame: At 1.5 hours after administration
|
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 1.5 hours.
|
At 1.5 hours after administration
|
|
Change in subjective effects measured with Addiction Research Center Inventory (ARCI)
Time Frame: From baseline to 8 hours after administration
|
Obtained baseline and 1, 2, 4, 6 and 8-h after administration
|
From baseline to 8 hours after administration
|
|
Change in blood pressure
Time Frame: From baseline to 8 hours after administration
|
Systolic and diastolic blood pressure (mmHg) will be measured obtained baseline and 0.5, 1, 1,5, 2, 3, 4, 6 and 8-h after administration.
|
From baseline to 8 hours after administration
|
|
Change in heart rate
Time Frame: From baseline to 8 hours after administration
|
Heart rate (bpm) will be measured obtained baseline and 0.5, 1, 1,5, 2, 3, 4, 6 and 8-h after administration.
|
From baseline to 8 hours after administration
|
|
Change in oral temperature
Time Frame: From baseline to 8 hours after administration
|
Oral temperature (ºC) will be measured obtained baseline and 0.5, 1, 1,5, 2, 3, 4, 6 and 8-h after administration.
|
From baseline to 8 hours after administration
|
|
Change in Maddox Wing score (MW)
Time Frame: From baseline to 4 hours after administration
|
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 1.5, 4-h after administration.
|
From baseline to 4 hours after administration
|
|
Hangover
Time Frame: At 8 hours and 12 hours after administration
|
Measured at 8 and 12h , with Alcohol Hangover Severity Scale
|
At 8 hours and 12 hours after administration
|
|
Change in anxiety
Time Frame: From baseline to 6 hours after administration
|
Measured with Anxiety-state scale (STAI-S) at baseline, 1,1,4, 6-h after administration
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From baseline to 6 hours after administration
|
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Beverage identification
Time Frame: At 8 hours after administration
|
Beverage identification questionnaire.There is an option to select each treatment condition.
Only measured at 8h after administration
|
At 8 hours after administration
|
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Urine volume generated
Time Frame: From baseline to 8 hours after administration
|
Mililiters of urine collected
|
From baseline to 8 hours after administration
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Clara Pérez Mañá, MD, PhD, Hospital Universitari Germans Trias i Pujol-IGTP
Publications and helpful links
General Publications
- White WL. Erratum to: Why I hate the index finger. Hand (N Y). 2011 Jun;6(2):233. doi: 10.1007/s11552-011-9321-0. Epub 2011 Mar 18.
- Garrisson H, Scholey A, Verster JC, Shiferaw B, Benson S. Effects of alcohol intoxication on driving performance, confidence in driving ability, and psychomotor function: a randomized, double-blind, placebo-controlled study. Psychopharmacology (Berl). 2022 Dec;239(12):3893-3902. doi: 10.1007/s00213-022-06260-z. Epub 2022 Nov 2.
- Mets MA, Ketzer S, Blom C, van Gerven MH, van Willigenburg GM, Olivier B, Verster JC. Positive effects of Red Bull(R) Energy Drink on driving performance during prolonged driving. Psychopharmacology (Berl). 2011 Apr;214(3):737-45. doi: 10.1007/s00213-010-2078-2. Epub 2010 Nov 10.
- Redondo B, Vera J, Carreno-Rodriguez C, Molina-Romero R, Jimenez R. Acute Effects of Caffeine on Dynamic Accommodative Response and Pupil Size: A Placebo-controlled, Double-blind, Balanced Crossover Study. Curr Eye Res. 2020 Sep;45(9):1074-1081. doi: 10.1080/02713683.2020.1725060. Epub 2020 Feb 11.
- McKetin R, Coen A, Kaye S. A comprehensive review of the effects of mixing caffeinated energy drinks with alcohol. Drug Alcohol Depend. 2015 Jun 1;151:15-30. doi: 10.1016/j.drugalcdep.2015.01.047. Epub 2015 Feb 24.
- Liguori A, Robinson JH. Caffeine antagonism of alcohol-induced driving impairment. Drug Alcohol Depend. 2001 Jul 1;63(2):123-9. doi: 10.1016/s0376-8716(00)00196-4.
- Howland J, Rohsenow DJ, Arnedt JT, Bliss CA, Hunt SK, Calise TV, Heeren T, Winter M, Littlefield C, Gottlieb DJ. The acute effects of caffeinated versus non-caffeinated alcoholic beverage on driving performance and attention/reaction time. Addiction. 2011 Feb;106(2):335-41. doi: 10.1111/j.1360-0443.2010.03219.x. Epub 2010 Dec 6.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HGTP/JB/PNSD/1
- 2024I013 (Other Identifier: Plan Nacional Sobre Drogas (PNSD))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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