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| ID | Type | Description | Link |
|---|---|---|---|
| HUGTP/ENERGYBINGE/PNSD/1 | Other Identifier | Hospital Universitari Germans Trias i Pujol |
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| Name | Class |
|---|---|
| Germans Trias i Pujol Hospital | OTHER |
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The purpose of the study is to assess the relevance of gender in the acute effects (subjective, physiological and driving-related skills) observed after controlled administration of alcohol in a binge-drinking pattern mixed with energy drinks (AmED)
Consumption of alcohol mixed with energy drinks (AmED) has increased mainly among young people. Energy drinks (ED) are usually combined with alcohol with the intention of counteracting its effects. However, most studies have not shown a reduction in drunkenness and consumption is related with engagement of risk-taking behaviours like driving under alcohol effects. It is already known that alcohol concentrations and effects are higher in women than in men even after adjusting dose by weight.
The relevance of gender in the acute effects of alcohol associated with ED consumed in a binge-drinking pattern has been poorly studied. A randomized clinical trial will be conducted in healthy volunteers (1:1) and four treatment conditions will be administered: alcohol+ED, alcohol+placebo of ED, placebo of alcohol+ED and placebo of alcohol+placebo of ED. Subjective and physiological effects, driving related skills, and alcohol and caffeine concentrations will be measured along an 8-hours period. A pilot study has been conducted with the first 6 volunteers to select the alcohol doses. In the definitive study 70 g of alcohol in men and 55 g in women will be used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alcohol and Energy Drink (AmED) | Experimental | The total volume of drink will be 761 ml in women and 969 ml in men. The doses will be divided into 6 fractions administered one every 15 min simulating a binge drinking pattern (80 min in total). Women: Ethanol 172 ml (55 g) + ED 589 ml Men: Ethanol 219 ml (70 g) + ED 750 ml |
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| Alcohol and Energy drink Placebo | Active Comparator | The total volume of drink will be 761 ml in women and 969 ml in men. The doses will be divided into 6 fractions administered one every 15 min simulating a binge drinking pattern (80 min in total). Women: Ethanol 172 mL (55 g) + placebo ED (a non-caffeinated soft drink) 589 mL Men: Ethanol 219 mL(70 g) + placebo ED 750 mL (a non-caffeinated soft drink) |
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| Alcohol placebo and Energy drink | Active Comparator | The total volume of drink will be 761 ml in women and 969 ml in men. The doses will be divided into 6 fractions administered one every 15 min simulating a binge drinking pattern (80 min in total). Women: Ethanol placebo (water) 172 mL + ED 589 mL Men: Ethanol placebo (water) 219 mL + ED 750 mL |
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| Alcohol placebo and Energy drink placebo | Placebo Comparator | The total volume of drink will be 761 ml in women and 969 ml in men. The doses will be divided into 6 fractions administered one every 15 min simulating a binge drinking pattern (80 min in total). Women: Ethanol placebo (water) 172 mL+ placebo ED (a non-caffeinated soft drink) 589 mL Men: Ethanol placebo (water) 219 mL + placebo ED (a non-caffeinated soft drinks) 750 mL |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alcohol and Energy Drink (AmED) | Dietary Supplement | Multiple oral dose of alcohol mixed with ED |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in subjective effects measured with Biphasic alcohol effects scale (BAES) | Subjective effects of alcohol will be measured using Biphasic alcohol effects scale (0-70 points). Higher scores mean worse outcome. Obtained baseline and 1, 1.30, 2, 3, 4, 6 and 8-h after administration. | From baseline to 8 hours after administration |
| Change in psychomotor vigilance task (PVT) | Test will be performed using a specific software. Mean latency will be measured. Obtained baseline and 1.30, 4 and 6-h after administration. | From baseline to 6 hours after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve (AUC 0-8h) of ethanol blood concentrations | Calculation of AUC of ethanol blood concentrations. Obtained baseline and 0.30h , 1, 1.30, 2, 2.30, 3, 4, 6 and 8-h after administration. | From baseline to 8 hours after administration |
| Area under the concentration-time curve (AUC 0-8h) of ethanol breath concentrations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clara Pérez-Mañá, MD,PhD | Contact | +34 93 497 88 65 | cperezm.mn.ics@gencat.cat | |
| Magi Farré, MD, PhD | Contact | +34 93 497 88 65 | mfarre.germanstrias@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-Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol (IGTP) | Recruiting | Badalona | Barcelona | 08916 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40487410 | Derived | 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. |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D003075 | Coitus |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D012725 | Sexual Behavior |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D061215 | Energy Drinks |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
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Double-blind
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| Alcohol and Energy drink Placebo | Dietary Supplement | Multiple oral dose of alcohol mixed with ED placebo (soft drink) |
|
| Alcohol placebo and Energy drink | Dietary Supplement | Multiple oral dose of alcohol placebo (water) mixed with ED |
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| Alcohol placebo and energy drink placebo | Dietary Supplement | Multiple oral dose of alcohol placebo (water) mixed with ED placebo (soft drink) |
|
Obtained baseline and 0.15, 0.30 , 0.45, 1, 1.15,1.30, 1.45, 2, 2.15, 2.30, 3, 4, 6 and 8-h after administration. |
| From baseline to 8 hours after administration |
| Area under the concentration-time curve (AUC 0-8h) of caffeine blood concentrations | Calculation of AUC of caffeine concentrations obtained baseline and 0.30, 1, 1.30, 2, 2.30, 3, 4, 6 and 8-h after administration. | From baseline to 8 hours after administration |
| Maximum concentration (Cmax) of ethanol in blood | Maximum concentration (Cmax) of ethanol in blood | From baseline to 8 hours after administration |
| Maximum concentration (Cmax) of caffeine in plasma | Maximum concentration (Cmax) of caffeine in plasma | From baseline to 8 hours after administration |
| Time to reach maximum concentration (tmax) of ethanol in blood | Time to reach maximum concentration (tmax) of ethanol in blood | 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 ethanol in breath air | From baseline to 8 hours after administration |
| Time to reach maximum concentration (tmax) of caffeine in plasma | Time to reach maximum concentration (tmax) of caffeine in plasma | From baseline to 8 hours after administration |
| Area under the concentration-time curve (AUC 0-8h) of taurine plasma concentrations | Calculation of AUC of taurine concentrations obtained baseline and 0.30h , 1, 1.30, 2, 2.30, 3, 4, 6 and 8-h after administration | From baseline to 8 hours after administration |
| Maximum concentration (Cmax) of taurine plasma concentrations | Maximum concentration (Cmax) of taurine plasma concentrations | From baseline to 8 hours after administration |
| Time to reach maximum concentration (tmax) of taurine plasma concentrations | Time to reach maximum concentration (tmax) of taurine plasma concentrations | 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 0.30, 1, 1.30, 2, 2.30, 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 0.30, 1, 1.30, 2, 2.30, 3, 4, 6 and 8-h after administration. | From baseline to 8 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 0.30, 1, 1.30, 2, 2.30, 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 0.30, 1, 1.30, 2, 2.30, 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 0.30, 1, 1.30, 2, 2.30, 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 0.30, 1, 1.30, 2, 2.30, 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 1.30, 4, 6 and 8-h after administration. | From baseline to 8 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 1.30 hours. | At 1.30 hours |
| Change in subjective effects measured with Addiction Research Center Inventory (ARCI) | Obtained baseline and 1, 1.45, 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 0.30, 1, 1.30, 2, 2.30, 3, 4, 6 and 8-h after administration. | From baseline to 8 hours after administration |
| Change in heart rate | Heart rate (beats/min) will be measured obtained baseline and 0.30, 1, 1.30, 2, 2.30, 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 0.30, 1, 1.30, 2, 2.30, 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 1.30, 4 and 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 | 8 hours after administration |
| Change in tracking test performance | Test will be performed using a computer program. Total time outside the road and number of errors will be measured. Obtained baseline and 1.30, 4 and 6-h after administration. | From baseline to 6 hours after administration |
| D010829 |
| Physiological Phenomena |
| D019602 | Food and Beverages |