Acute Effects of Jägermeister With Energy Drinks (Jägermbomb)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorFundació Institut Germans Trias i Pujol
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Jägermeister and Energy Drink (Jägerbomb)
Dietary supplementMultiple oral dose of Jägermeister mixed with ED
Jägermeister and Energy Drink Placebo
Dietary supplementMultiple oral dose of Jägermeister mixed with a placebo of ED (non-caffeinated soft drink)
Alcohol Placebo and Energy Drink Placebo
Dietary supplementMultiple oral dose of alcohol placebo (water) mixed with ED placebo (non-caffeinated soft drink)
Treatment groups
24 Participants
are divided into 3 treatment groupsGroup A: Alcohol (Jägermeister) and Energy Drink: JägerbombExperimental treatment 1 intervention
Group B: Alcohol (Jägermeister) and Energy Drink PlaceboActive comparator 1 intervention
Group C: Alcohol placebo and Energy Drink PlaceboPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
From baseline to 4 hours after administrationSecondary outcomes
1
Maximum concentration (Cmax) of ethanol in breath air
Maximum concentration (Cmax) of ethanol in breath air
Time frame
From baseline to 8 hours after administration2
Maximum concentration (Cmax) of caffeine in oral fluid
Maximum concentration (Cmax) of caffeine in oral fluid
Time frame
From baseline to 6 hours after administration3
Area under the concentration-time curve (AUC 0-8h) of ethanol breath concentrations
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.
Time frame
From baseline to 8 hours after administration4
Area under the concentration-time curve (AUC 0-6h) of caffeine oral fluid concentrations
Calculation of AUC of caffeine concentrations obtained baseline and 1, 1.5, 2, 4, 6-h after administration.
Time frame
From baseline to 6 hours after administrationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Fundació Institut Germans Trias i Pujol
Lead sponsor
Plan Nacional sobre Drogas
Collaborator
Source ClinicalTrials.gov