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| ID | Type | Description | Link |
|---|---|---|---|
| 2024I013 | Other Identifier | Plan Nacional Sobre Drogas (PNSD) |
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| Name | Class |
|---|---|
| Plan Nacional sobre Drogas | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jägermeister and Energy Drink (Jägerbomb) | Dietary Supplement | Multiple oral dose of Jägermeister mixed with ED |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) of ethanol in breath air | Maximum concentration (Cmax) of ethanol in breath air | From baseline to 8 hours after administration |
| Maximum concentration (Cmax) of caffeine in oral fluid |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clara Pérez-Mañá, MD, PhD | Contact | +34934978865 | cperezm.mn.ics@gencat.cat | |
| Soraya Martín | Contact | +34934973831 | smartins.mn.ics@gencat.cat |
| Name | Affiliation | Role |
|---|---|---|
| Clara Pérez Mañá, MD, PhD | Hospital Universitari Germans Trias i Pujol-IGTP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Germans Trias i Pujol-IGTP | Recruiting | Barcelona | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21063868 | Background | 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. | |
| 21776199 | Background | 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. |
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IPD will not be shared as the dataset is subject to ongoing analyses and planned future publications.
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| Jägermeister and Energy Drink Placebo | Dietary Supplement | Multiple oral dose of Jägermeister mixed with a placebo of ED (non-caffeinated soft drink) |
|
| Alcohol Placebo and Energy Drink Placebo | Dietary Supplement | Multiple oral dose of alcohol placebo (water) mixed with ED placebo (non-caffeinated soft drink) |
|
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 | 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 | 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 ethanol in breath air | Time to reach maximum concentration (tmax) of ethanol in breath air | From baseline to 8 hours after administration |
| Time to reach maximum concentration (tmax) of caffeine in oral fluid | 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 | 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 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 | 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 | 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 | 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 | Pupillary diameter will be measured with a manual pupilometer | From baseline to 4 hours after administration |
| Change in drowsiness feeling | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | Obtained baseline and 1, 2, 4, 6 and 8-h after administration | From baseline to 8 hours after administration |
| Change in blood pressure | 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 | 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 | 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) | 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 | Measured at 8 and 12h , with Alcohol Hangover Severity Scale | At 8 hours and 12 hours after administration |
| Change in anxiety | 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 | 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 | Mililiters of urine collected | From baseline to 8 hours after administration |
| 32011181 | Background | 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. |
| 25861944 | Background | 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. |
| 11376916 | Background | 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. |
| 36322184 | Background | 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. |
| 21134017 | Background | 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. |
| 34338762 | Background | 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. |
| 40487410 | Background | 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. |
| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D063425 | Binge Drinking |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D061215 | Energy Drinks |
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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