NCT02771587

Brief Summary

The main objective of the project is to assess whether there is an interaction between the effects of ethanol and energy drinks on driving performance. Secondary objectives include: to evaluate subjective effects (drunkenness) after administration of alcohol and energy drinks, to assess pharmacokinetics of alcohol, caffeine and taurine after alcohol and energy drinks administration and to assess if there is an increased risk of bleeding when both drinks are taken together.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 13, 2016

Completed
19 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 19, 2016

Status Verified

October 1, 2016

Enrollment Period

3 months

First QC Date

May 10, 2016

Last Update Submit

October 18, 2016

Conditions

Alcohol-Related DisordersDrinking and Driving

Keywords

alcoholenergy drinkcoagulabilitycaffeinetaurinedriving performance

Outcome Measures

Primary Outcomes (1)

  • Change in tracking test performance

    The total time outside the road will be measured in the tracking test

    From baseline till 4 hours after administration

Secondary Outcomes (30)

  • Change in simple reaction time (SRT)

    From baseline till 4 hours after administration

  • Change in movement estimation

    From baseline till 4 hours after administration

  • Change in memory function

    From baseline till 4 hours after administration

  • Change in drunkenness

    From baseline till 8 hours after administration

  • Change in drowsiness

    From baseline till 8 hours after administration

  • +25 more secondary outcomes

Study Arms (4)

Alcohol and energy drink

EXPERIMENTAL

Alcohol 60 g, multiple dose (30 g+30 g), oral administration. 3 energy drinks (750 ml), multiple dose (375 ml+375 ml), oral administration.

Dietary Supplement: Alcohol and energy drink

Alcohol

ACTIVE COMPARATOR

Alcohol 60 g, multiple dose (30 g+30 g), oral administration. 3 non-caffeinated soft drinks (750 ml), multiple dose (375 ml+375 ml), oral administration.

Dietary Supplement: Alcohol

Energy drink

ACTIVE COMPARATOR

3 energy drinks (750 ml), multiple dose (375 ml+ 375 ml), oral administration. Font Vella water (188ml), multiple dose (94 ml+ 94 ml), oral administration.

Dietary Supplement: Energy drink

Placebo

PLACEBO COMPARATOR

3 non-caffeinated soft drinks (750 ml), multiple dose (375 ml+375 ml), oral administration. Font Vella water (188ml), multiple dose (94 ml+ 94 ml), oral administration.

Dietary Supplement: Placebo

Interventions

Alcohol and energy drinkDIETARY_SUPPLEMENT

Multiple oral dose of alcohol Multiple oral dose of energy drink

Alcohol and energy drink
AlcoholDIETARY_SUPPLEMENT

Multiple oral dose of alcohol

Alcohol
Energy drinkDIETARY_SUPPLEMENT

Multiple oral dose of energy drink

Energy drink
PlaceboDIETARY_SUPPLEMENT

Multiple oral dose of water Multiple oral dose of non-caffeinated soft drink

Also known as: Non-active treatment
Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • EKG, blood and urine tests taken before entry into the study within the normal range. Minor and transient abnormalities may be acceptable if, according to the Principal Investigator's criterion and the state of the art, they are felt to have no clinical relevance, entail no danger to the participant, and don't interfere with the product's assessment. These abnormalities and their non-relevance must be specifically justified in writing)
  • Body mass index (BMI=weight/heigth2) between 19 and 27 kg/m2, weight between 50 and 100 kg
  • For premenopausal females, a regular menstrual cycle of 26-32 days duration.
  • Social or recreational alcohol consumption of at least 1 unit per day (or its equivalent \[7 units\] over the whole week) and having experienced drunkenness several times
  • Regular consumption of beverages containing methylxanthines (at least 5 per week)
  • Consumption of energy drinks several times previously
  • Having a driving license

You may not qualify if:

  • Evidence of a preexisting condition (including gastrointestinal, liver, or kidney disorders) that may alter the absorption, distribution, metabolism or excretion of the drug or symptoms suggestive of drug-induced gastrointestinal irritation
  • Previous 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
  • Individuals intolerant or having experienced a severe adverse reaction to alcohol or energy drinks
  • Smokers of \>5 cigarettes/day
  • Consumption of \>20 g/day of alcohol (females) or of \>40 g/day (males)
  • Hepatitis B, hepatitis C or human immunodeficiency virus-positive individuals
  • Pregnant or lactating women, or those using hormonal or unreliable contraceptive methods during the study period. Complete abstinence, intrauterine devices, double barrier methods or a vasectomized sexual partner will be considered acceptable
  • Women with amenorrhea or suffering severe premenstrual syndrome
  • Individuals of Asian ascent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

IMIM

Barcelona, Barcelona, 08003, Spain

Location

Parc de Salut Mar-IMIM

Barcelona, Barcelona, 08003, Spain

Location

Related Publications (1)

  • 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.

    PMID: 34338762DERIVED

MeSH Terms

Conditions

Alcohol-Related DisordersDriving Under the Influence

Interventions

EthanolEnergy Drinks

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersCriminal BehaviorBehaviorDangerous Behavior

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Clara Pérez Mañá, PhD, MD

    IMIM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 10, 2016

First Posted

May 13, 2016

Study Start

June 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

October 19, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)