Clinical trial NCT04616859: Binge Drinking of Alcohol Mixed With Energy Drinks
Official title: Combination of Alcohol and Energy Drinks in a Binge Drinking Pattern: Acute Effects and Gender Differences
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Alcohol Drinking
Keywords: alcohol binge drinking
alcohol
energy drinks
pharmacokinetics
caffeine
gender
Lead sponsor: Fundació Institut Germans Trias i Pujol
Sponsor class: OTHER
Collaborators: name: Germans Trias i Pujol Hospital
First posted: 2020-11-05
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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)

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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
3. 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.
4. Understand and accept the study's procedures and sign an informed consent form.
5. No evidence of somatic or psychiatric disorders as per past medical history and physical examination.
6. 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.

Exclusion Criteria:

1. Not fill the inclusion criteria.
2. 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.
3. 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.
4. Previous or actual psychiatric disorders, alcoholism, abuse of prescription drugs or illegal substances or regular consumption of psychoactive drugs.
5. 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
6. Having had any somatic disease or having undergone major surgery in the 3 months prior to inclusion in the trial.
7. 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.
8. 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.
9. Smokers of \>5 cigarettes/day
10. Consumption of \>20 g/day of alcohol (females) or of \>40 g/day (males)
11. 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.
12. Subjects unable to understand the nature, consequences of the study and the procedures requested to be followed.
13. Subjects with positive serology to Hepatitis B, C or HIV.
14. Pregnant, breastfeeding women and those using hormonal contraception,. Those not using an effective contraceptive (i.e. abstinence, intrauterine devices, barrier methods or partner vasectomy).
15. Women with amenorrhea or suffering severe premenstrual syndrome.

Primary outcomes:
measure: Change in subjective effects measured with Biphasic alcohol effects scale (BAES)
timeFrame: From baseline to 8 hours after administration
measure: Change in psychomotor vigilance task (PVT)
timeFrame: From baseline to 6 hours after administration
Secondary outcomes:
measure: Area under the concentration-time curve (AUC 0-8h) of ethanol blood concentrations
timeFrame: From baseline to 8 hours after administration
measure: Area under the concentration-time curve (AUC 0-8h) of ethanol breath concentrations
timeFrame: From baseline to 8 hours after administration
measure: Area under the concentration-time curve (AUC 0-8h) of caffeine blood concentrations
timeFrame: From baseline to 8 hours after administration
measure: Maximum concentration (Cmax) of ethanol in blood
timeFrame: From baseline to 8 hours after administration
measure: Maximum concentration (Cmax) of caffeine in plasma
timeFrame: From baseline to 8 hours after administration
measure: Time to reach maximum concentration (tmax) of ethanol in blood
timeFrame: From baseline to 8 hours after administration
measure: Time to reach maximum concentration (tmax) of ethanol in breath air
timeFrame: From baseline to 8 hours after administration
measure: Time to reach maximum concentration (tmax) of caffeine in plasma
timeFrame: From baseline to 8 hours after administration
measure: Area under the concentration-time curve (AUC 0-8h) of taurine plasma concentrations
timeFrame: From baseline to 8 hours after administration
measure: Maximum concentration (Cmax) of taurine plasma concentrations
timeFrame: From baseline to 8 hours after administration
measure: Time to reach maximum concentration (tmax) of taurine plasma concentrations
timeFrame: From baseline to 8 hours after administration
measure: Change in drunkenness feeling
timeFrame: From baseline to 8 hours after administration
measure: Change in dizziness feeling
timeFrame: From baseline to 8 hours after administration
measure: Change in drowsiness feeling
timeFrame: From baseline to 8 hours after administration
measure: Change in palpitations reported by the participant
timeFrame: From baseline to 8 hours after administration
measure: Change in anxiety feeling
timeFrame: From baseline to 8 hours after administration
measure: Change in headache
timeFrame: From baseline to 8 hours after administration
measure: Change in ability and predisposition to drive in certain situations
timeFrame: From baseline to 8 hours after administration
measure: Desire to keep drinking
timeFrame: At 1.30 hours
measure: Change in subjective effects measured with Addiction Research Center Inventory (ARCI)
timeFrame: From baseline to 8 hours after administration
measure: Change in blood pressure
timeFrame: From baseline to 8 hours after administration
measure: Change in heart rate
timeFrame: From baseline to 8 hours after administration
measure: Change in oral temperature
timeFrame: From baseline to 8 hours after administration
measure: Change in Maddox Wing score (MW)
timeFrame: From baseline to 6 hours after administration
measure: Beverage identification
timeFrame: 8 hours after administration
measure: Change in tracking test performance
timeFrame: From baseline to 6 hours after administration
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol-Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol (IGTP)
state: Barcelona
Study officials:
affiliation: Hospital Universitari Germans Trias i Pujol-IGTP
name: Clara Pérez-Mañá, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: