HealthyENERGYBINGENCT04616859
Binge Drinking of Alcohol Mixed With Energy Drinks
A study testing Alcohol and Energy Drink (AmED) in people with Healthy and Alcohol Drinking, run by Fundació Institut Germans Trias i Pujol at 1 site in Spain.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Alcohol Drinking
- What is being tested?
- Alcohol and Energy Drink (AmED)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 8 Oct 2020to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females between 18-40 years old, weight between 50 and 100 kg and BMI (BMI=weight/height²) between 20-28 kg/m². Lower or higher BMIs will be allowed, if the researchers considered that do not suppose a risk to the subjects and do not interfere with the objectives of the study.
- Recreational alcohol consumption in form of occasional binge-drinking (≥1 episode / month) and at least consumption of 1 unit (10 g, "standard" drink - one alcoholic drink equivalent) per day or its equivalent over the whole week [7 units, 70 g)]) and having experienced drunkenness several times
- Regular consumption of beverages containing methylxanthines at least 7 per week (coffee, tea, chocolate, cola soda, energy drinks). Consumption of energy drinks at least once.
- Understand and accept the study's procedures and sign an informed consent form.
- No evidence of somatic or psychiatric disorders as per past medical history and physical examination.
- The ECG and general blood and urine laboratory tests performed before the study should be within normal ranges. Minor or occasional changes from normal ranges are accepted if, in the investigator's opinion, considering the current state of the art, they are not clinically significant, are not life-threatening for the subjects and do not interfere with the product assessment. These changes and their non-relevance will be justified in writing specifically.
Who cannot join
- Not fill the inclusion criteria.
- Pathological history or evidence of a preexisting condition (including gastrointestinal, liver, or kidney disorders) that may alter the absorption, distribution, metabolism or excretion of drugs or symptoms suggestive of drug-induced gastrointestinal irritation.
- Present history of a substance use disorder according to Diagnostic and Statistical Manual for Mental Disorders (DSM-V), except for nicotine. Past history of mild substance use disorder (corresponding to substance abuse according to DSM-IV) could be included.
- Previous or actual psychiatric disorders, alcoholism, abuse of prescription drugs or illegal substances or regular consumption of psychoactive drugs.
- Having donated blood or having participated in this same study in the preceding 8 weeks, or having participated in any clinical trial with drugs in the preceding 12 weeks
- Having had any somatic disease or having undergone major surgery in the 3 months prior to inclusion in the trial.
Show all 15Show fewer
- Individuals intolerant or having experienced a severe adverse reaction to alcohol or energy drinks. Asian subjects with no intolerance or no serious adverse reactions to alcohol could be included.
- Having regularly taken medication in the month before the trial, except for vitamins, herb-based remedies, dietary supplements that if, according to the Principal Investigator or his appointed collaborators' opinion, they pose no threat to the subjects and they won't interfere with the study's objectives. Single doses of symptomatic drugs taken during the week before the experimental session will not constitute an exclusion criterion if it can be assumed that it has been completely eliminated on the day of the experimental session.
- Smokers of >5 cigarettes/day
- Consumption of >20 g/day of alcohol (females) or of >40 g/day (males)
- Daily consumption of more than 5 coffees, teas, cola drinks or other stimulant or xanthine-containing beverages in the 3 months prior to inclusion in the study.
- Subjects unable to understand the nature, consequences of the study and the procedures requested to be followed.
- Subjects with positive serology to Hepatitis B, C or HIV.
- Pregnant, breastfeeding women and those using hormonal contraception,. Those not using an effective contraceptive (i.e. abstinence, intrauterine devices, barrier methods or partner vasectomy).
- Women with amenorrhea or suffering severe premenstrual syndrome.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Germans Trias i Pujol-Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol (IGTP)
Badalona, Barcelona, 08916
Clara Pérez-Mañá, MD, PhD, +34 934978865, cperezm.mn.ics@gencat.cat
Magi Farré, MD,PhD, +34 934978865, mfarre.germanstrias@gencat.cat
About this study
Official title: Combination of Alcohol and Energy Drinks in a Binge Drinking Pattern: Acute Effects and Gender Differences
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)
Read the detailed description
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.
- Conditions
- Healthy, Alcohol Drinking
- Being tested
- Alcohol and Energy Drink (AmED), Alcohol and Energy drink Placebo, Alcohol placebo and Energy drink, Alcohol placebo and energy drink placebo
- Keywords
- alcohol binge drinking, alcohol, energy drinks, pharmacokinetics, caffeine, gender
- Medical subject headings
- Alcohol Drinking, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol and Energy Drink (AmED)Dietary supplement
Multiple oral dose of alcohol mixed with ED
Alcohol and Energy drink PlaceboDietary supplement
Multiple oral dose of alcohol mixed with ED placebo (soft drink)
Alcohol placebo and Energy drinkDietary supplement
Multiple oral dose of alcohol placebo (water) mixed with ED
Alcohol placebo and energy drink placeboDietary supplement
Multiple oral dose of alcohol placebo (water) mixed with ED placebo (soft drink)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Alcohol and Energy Drink (AmED) |
| 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) Receives: Dietary Supplement: Alcohol and Energy drink Placebo |
| 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 Receives: Dietary Supplement: Alcohol placebo and Energy drink |
| 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 Receives: Dietary Supplement: Alcohol placebo and energy drink placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From baseline to 6 hours after administration
Secondary outcomes (26)
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.
Measured: From baseline to 8 hours after administration
Area under the concentration-time curve (AUC 0-8h) of ethanol breath concentrations
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.
Measured: 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.
Measured: From baseline to 8 hours after administration
Maximum concentration (Cmax) of ethanol in blood
Maximum concentration (Cmax) of ethanol in blood
Measured: From baseline to 8 hours after administration
Maximum concentration (Cmax) of caffeine in plasma
Maximum concentration (Cmax) of caffeine in plasma
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From baseline to 8 hours after administration
Maximum concentration (Cmax) of taurine plasma concentrations
Maximum concentration (Cmax) of taurine plasma concentrations
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: From baseline to 6 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start8 Oct 2020
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Institut Germans Trias i Pujol
- Sponsor type
- University, hospital or other
- Collaborators
- Germans Trias i Pujol Hospital
- Responsible party
- Sponsor
- Investigators
- Clara Pérez-Mañá, MD, PhD, Principal investigator, Hospital Universitari Germans Trias i Pujol-IGTP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616859
- Sponsor's protocol ID
- HUGTP/ENERGYBINGE/PNSD/1
- Other IDs
- HUGTP/ENERGYBINGE/PNSD/1
- Acronym
- ENERGYBINGE
- Status last verified
- Nov 2020
- First submitted
- 30 Oct 2020
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40487410
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Alcohol and Energy Drinks in a Binge Drinking Pattern: Acute Effects and Gender Differences
- ClinicalTrials.gov ID
- NCT04616859
- Acronym / sponsor ID
- ENERGYBINGE / HUGTP/ENERGYBINGE/PNSD/1
- Conditions
- Healthy, Alcohol Drinking
- Keywords
- alcohol binge drinking, alcohol, energy drinks, pharmacokinetics, caffeine, gender
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Fundació Institut Germans Trias i PujolUniversity, hospital or other
- Collaborators
- Germans Trias i Pujol Hospital
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 5 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Alcohol and Energy Drink (AmED) | Experimental | Dietary Supplement: Alcohol and Energy Drink (AmED)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 |
| Alcohol and Energy drink Placebo | Active comparator | Dietary Supplement: Alcohol and Energy drink PlaceboThe 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) |
| Alcohol placebo and Energy drink | Active comparator | Dietary Supplement: Alcohol placebo and Energy drinkThe 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 |
| Alcohol placebo and Energy drink placebo | Placebo comparator | Dietary Supplement: Alcohol placebo and energy drink placeboThe 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males and females between 18-40 years old, weight between 50 and 100 kg and BMI (BMI=weight/height²) between 20-28 kg/m². Lower or higher BMIs will be allowed, if the researchers considered that do not suppose a risk to the subjects and do not interfere with the objectives of the study.
- Recreational alcohol consumption in form of occasional binge-drinking (≥1 episode / month) and at least consumption of 1 unit (10 g, "standard" drink - one alcoholic drink equivalent) per day or its equivalent over the whole week [7 units, 70 g)]) and having experienced drunkenness several times
- Regular consumption of beverages containing methylxanthines at least 7 per week (coffee, tea, chocolate, cola soda, energy drinks). Consumption of energy drinks at least once.
- Understand and accept the study's procedures and sign an informed consent form.
- No evidence of somatic or psychiatric disorders as per past medical history and physical examination.
Key exclusion criteria (15 listed)
- Not fill the inclusion criteria.
- Pathological history or evidence of a preexisting condition (including gastrointestinal, liver, or kidney disorders) that may alter the absorption, distribution, metabolism or excretion of drugs or symptoms suggestive of drug-induced gastrointestinal irritation.
- Present history of a substance use disorder according to Diagnostic and Statistical Manual for Mental Disorders (DSM-V), except for nicotine. Past history of mild substance use disorder (corresponding to substance abuse according to DSM-IV) could be included.
- Previous or actual psychiatric disorders, alcoholism, abuse of prescription drugs or illegal substances or regular consumption of psychoactive drugs.
- Having donated blood or having participated in this same study in the preceding 8 weeks, or having participated in any clinical trial with drugs in the preceding 12 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol and Energy Drink (AmED)Multiple oral dose of alcohol mixed with ED | Dietary supplement | Alcohol and Energy Drink (AmED) |
| Alcohol and Energy drink PlaceboMultiple oral dose of alcohol mixed with ED placebo (soft drink) | Dietary supplement | Alcohol and Energy drink Placebo |
| Alcohol placebo and Energy drinkMultiple oral dose of alcohol placebo (water) mixed with ED | Dietary supplement | Alcohol placebo and Energy drink |
| Alcohol placebo and energy drink placeboMultiple oral dose of alcohol placebo (water) mixed with ED placebo (soft drink) | Dietary supplement | Alcohol placebo and Energy drink placebo |
Primary outcome
Change in subjective effects measured with Biphasic alcohol effects scale (BAES)
Time frame: From baseline to 8 hours after administration
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.
Change in psychomotor vigilance task (PVT)
Time frame: From baseline to 6 hours after administration
Test will be performed using a specific software. Mean latency will be measured. Obtained baseline and 1.30, 4 and 6-h after administration.
26 secondary outcomes
Area under the concentration-time curve (AUC 0-8h) of ethanol blood concentrations
Time frame: From baseline to 8 hours after administration
Area under the concentration-time curve (AUC 0-8h) of ethanol breath concentrations
Time frame: From baseline to 8 hours after administration
Area under the concentration-time curve (AUC 0-8h) of caffeine blood concentrations
Time frame: From baseline to 8 hours after administration
Maximum concentration (Cmax) of ethanol in blood
Time frame: From baseline to 8 hours after administration
Maximum concentration (Cmax) of caffeine in plasma
Time frame: From baseline to 8 hours after administration
Time to reach maximum concentration (tmax) of ethanol in blood
Time frame: From baseline to 8 hours after administration
Time to reach maximum concentration (tmax) of ethanol in breath air
Time frame: From baseline to 8 hours after administration
Time to reach maximum concentration (tmax) of caffeine in plasma
Time frame: From baseline to 8 hours after administration
Area under the concentration-time curve (AUC 0-8h) of taurine plasma concentrations
Time frame: From baseline to 8 hours after administration
Maximum concentration (Cmax) of taurine plasma concentrations
Time frame: From baseline to 8 hours after administration
Time to reach maximum concentration (tmax) of taurine plasma concentrations
Time frame: From baseline to 8 hours after administration
Change in drunkenness feeling
Time frame: From baseline to 8 hours after administration
Change in dizziness feeling
Time frame: From baseline to 8 hours after administration
Change in drowsiness feeling
Time frame: From baseline to 8 hours after administration
Change in palpitations reported by the participant
Time frame: From baseline to 8 hours after administration
Change in anxiety feeling
Time frame: From baseline to 8 hours after administration
Change in headache
Time frame: From baseline to 8 hours after administration
Change in ability and predisposition to drive in certain situations
Time frame: From baseline to 8 hours after administration
Desire to keep drinking
Time frame: At 1.30 hours
Change in subjective effects measured with Addiction Research Center Inventory (ARCI)
Time frame: From baseline to 8 hours after administration
Change in blood pressure
Time frame: From baseline to 8 hours after administration
Change in heart rate
Time frame: From baseline to 8 hours after administration
Change in oral temperature
Time frame: From baseline to 8 hours after administration
Change in Maddox Wing score (MW)
Time frame: From baseline to 6 hours after administration
Beverage identification
Time frame: 8 hours after administration
Change in tracking test performance
Time frame: From baseline to 6 hours after administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Derived from this study: PubMed 40487410Hladun 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clara Pérez-Mañá, MD, PhD principal investigator
Hospital Universitari Germans Trias i Pujol-IGTP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol and Energy Drink (AmED) in people with Healthy and Alcohol Drinking, run by Fundació Institut Germans Trias i Pujol at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clara Pérez-Mañá, MD,PhD (+34 93 497 88 65, cperezm.mn.ics@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in subjective effects measured with Biphasic alcohol effects scale (BAES) (time frame: From baseline to 8 hours after administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04616859, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2020.