Alcohol Drinking, Binge Alcohol Consumption, Energy Drinks, Healthy Adult Participants
Conditions
Keywords
Binge drinking, Jägerbomb, Alcohol, Psychomotor performance
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.
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.
Interventions
DIETARY_SUPPLEMENTJägermeister and Energy Drink (Jägerbomb)
Multiple oral dose of Jägermeister mixed with ED
DIETARY_SUPPLEMENTJägermeister and Energy Drink Placebo
Multiple oral dose of Jägermeister mixed with a placebo of ED (non-caffeinated soft drink)
DIETARY_SUPPLEMENTAlcohol Placebo and Energy Drink Placebo
Multiple oral dose of alcohol placebo (water) mixed with ED placebo (non-caffeinated soft drink)
Sponsors
Fundació Institut Germans Trias i Pujol
Plan Nacional sobre Drogas
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in reaction time (Psychomotor Vigilance Task) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in drunkenness feeling | 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 |
| Change in dizziness feeling | 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 |
| Change in palpitations reported by the participant | 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. |
| Change in anxiety feeling | 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. |
| Change in headache | 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. |
| Change in ability and predisposition to drive in certain situations | 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. |
| Desire to keep drinking | 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. |
| Change in subjective effects measured with Addiction Research Center Inventory (ARCI) | From baseline to 8 hours after administration | Obtained baseline and 1, 2, 4, 6 and 8-h after administration |
| Change in blood pressure | 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. |
| Change in heart rate | 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. |
| Change in oral temperature | 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. |
| Change in Maddox Wing score (MW) | 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. |
| Hangover | At 8 hours and 12 hours after administration | Measured at 8 and 12h , with Alcohol Hangover Severity Scale |
| Change in anxiety | From baseline to 6 hours after administration | Measured with Anxiety-state scale (STAI-S) at baseline, 1,1,4, 6-h after administration |
| Beverage identification | At 8 hours after administration | Beverage identification questionnaire.There is an option to select each treatment condition. Only measured at 8h after administration |
| Urine volume generated | From baseline to 8 hours after administration | Mililiters of urine collected |
| Change in pupillary diameter | From baseline to 4 hours after administration | Pupillary diameter will be measured with a manual pupilometer |
| Maximum concentration (Cmax) of ethanol in breath air | From baseline to 8 hours after administration | Maximum concentration (Cmax) of ethanol in breath air |
| Maximum concentration (Cmax) of caffeine in oral fluid | From baseline to 6 hours after administration | Maximum concentration (Cmax) of caffeine in oral fluid |
| Area under the concentration-time curve (AUC 0-8h) of ethanol breath concentrations | 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. |
| Area under the concentration-time curve (AUC 0-6h) of caffeine oral fluid concentrations | 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. |
| 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 ethanol in breath air |
| Time to reach maximum concentration (tmax) of caffeine in oral fluid | From baseline to 6 hours after administration | Time to reach maximum concentration (tmax) of caffeine in oral fluid |
| Maximum concentration (Cmax) of cortisol in oral fluid | From baseline till 6 hours after administration | Maximum concentration (Cmax) of cortisol in oral fluid |
| Time to reach maximum concentration (tmax) of saliva in oral fluid | From baseline to 6 hours after administration | Time to reach maximum concentration (tmax) of saliva in oral fluid |
| Area under the concentration-time curve (AUC 0-6h) of cortisol concentrations in oral fluid | 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. |
| Change in visual acuity | 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 |
| Change in drowsiness feeling | 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. |
| Change in unstable tracking task | 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. |
Countries
Spain
Contacts
CONTACTClara Pérez-Mañá, MD, PhD
CONTACTSoraya Martín
PRINCIPAL_INVESTIGATORClara Pérez Mañá, MD, PhD
Hospital Universitari Germans Trias i Pujol-IGTP
Outcome results
None listed