NCT07588022

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
13mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Feb 2026Jun 2027

Study Start

First participant enrolled

February 18, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 14, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

May 14, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

May 4, 2026

Last Update Submit

May 8, 2026

Conditions

Keywords

Binge drinkingJägerbombAlcoholPsychomotor performance

Outcome Measures

Primary Outcomes (1)

  • Change in reaction time (Psychomotor Vigilance Task)

    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 Outcomes (29)

  • Maximum concentration (Cmax) of ethanol in breath air

    From baseline to 8 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

    From baseline to 8 hours after administration

  • Area under the concentration-time curve (AUC 0-6h) of caffeine oral fluid concentrations

    From baseline to 6 hours after administration

  • Time to reach maximum concentration (tmax) of ethanol in breath air

    From baseline to 8 hours after administration

  • +24 more secondary outcomes

Study Arms (3)

Alcohol (Jägermeister) and Energy Drink: Jägerbomb

EXPERIMENTAL

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)

Dietary Supplement: Jägermeister and Energy Drink (Jägerbomb)

Alcohol (Jägermeister) and Energy Drink Placebo

ACTIVE COMPARATOR

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.

Dietary Supplement: Jägermeister and Energy Drink Placebo

Alcohol placebo and Energy Drink Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Alcohol Placebo and Energy Drink Placebo

Interventions

Multiple oral dose of Jägermeister mixed with ED

Alcohol (Jägermeister) and Energy Drink: Jägerbomb

Multiple oral dose of Jägermeister mixed with a placebo of ED (non-caffeinated soft drink)

Alcohol (Jägermeister) and Energy Drink Placebo

Multiple oral dose of alcohol placebo (water) mixed with ED placebo (non-caffeinated soft drink)

Alcohol placebo and Energy Drink Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • \) Have suffered any organic disease or major surgery in the three months prior to the start of the study.
  • \) 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.
  • \) 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.
  • \) Subjects who are not able to understand the nature of the trial and the procedures they are asked to follow.
  • \) 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).
  • \) Women with amenorrhea or premenstrual syndrome of severe intensity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari Germans Trias i Pujol-IGTP

Barcelona, Spain

RECRUITING

Related Publications (9)

  • 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.

    PMID: 21063868BACKGROUND
  • 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.

    PMID: 21776199BACKGROUND
  • 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.

    PMID: 32011181BACKGROUND
  • 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.

    PMID: 25861944BACKGROUND
  • 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.

    PMID: 11376916BACKGROUND
  • 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.

    PMID: 36322184BACKGROUND
  • 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.

    PMID: 21134017BACKGROUND
  • 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.

    PMID: 34338762BACKGROUND
  • 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: 40487410BACKGROUND

MeSH Terms

Conditions

Alcohol DrinkingBinge Drinking

Interventions

Energy DrinksEthanol

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesAlcoholsOrganic Chemicals

Study Officials

  • Clara Pérez Mañá, MD, PhD

    Hospital Universitari Germans Trias i Pujol-IGTP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clara Pérez-Mañá, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2026

First Posted

May 14, 2026

Study Start

February 18, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

May 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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

Locations