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

The main objective of this study is to compare the acute effects of drinking Jägerbombs with drinking alcohol alone during a binge-drinking episode, which involves consuming a large amount of alcohol in a short period of time to become intoxicated. Secondary objectives are to assess whether Jägerbombs produce prototypical alcohol effects, increase stimulation and rewarding effects, affect coordination, time reaction and vision, change stress-related hormone responses, and cause hangover symptoms.

Study Overview

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

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Barcelona, Spain
        • Recruiting
        • Hospital Universitari Germans Trias i Pujol-IGTP
        • Principal Investigator:
          • Clara Pérez-Mañá, MD, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. 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.
  2. Alcohol consumption in the form of occasional binge drinking (≥1 time/month), social alcohol consumption (≥10g/day distributed weekly) and experience in alcohol intoxication.
  3. Consumption ≥7 drinks with methylxanthines (coffee, tea, chocolate, cola, BE) per week and who have consumed ED on at least one occasion.
  4. Understand and agree to the trial procedures and sign an informed consent.
  5. History and physical examination that demonstrate no organic or psychiatric disorders.
  6. 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:

  1. Not meeting the inclusion criteria.
  2. 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.
  3. 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.
  4. History or clinical evidence of psychiatric disorders, alcoholism, abuse of drugs or other drugs or habitual consumption of psychoactive drugs.
  5. 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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)
Multiple oral dose of Jägermeister mixed with ED
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.
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.
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
From baseline to 8 hours after administration
Maximum concentration (Cmax) of ethanol in breath air
Time Frame: From baseline to 8 hours after administration
Maximum concentration (Cmax) of ethanol in breath air
From baseline to 8 hours after administration
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
From baseline to 6 hours after administration
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
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
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
From baseline to 6 hours after administration
Maximum concentration (Cmax) of cortisol in oral fluid
Time Frame: From baseline till 6 hours after administration
Maximum concentration (Cmax) of cortisol in oral fluid
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
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.
From baseline to 8 hours after administration
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
From baseline to 6 hours after administration
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
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Clara Pérez Mañá, MD, PhD, Hospital Universitari Germans Trias i Pujol-IGTP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

May 4, 2026

First Submitted That Met QC Criteria

May 8, 2026

First Posted (Actual)

May 14, 2026

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared as the dataset is subject to ongoing analyses and planned future publications.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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