Acute effects of Jägerbombs with energy drinks during a binge for healthy adults

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.