Perceived Alcohol IntoxicationNCT01350089
Possible Effects of Energy Drink Ingestion on Perceived Alcohol Intoxication
A study testing Comparator 1 (with alcohol; without caffeine and energy drink), Comparator 2 (with alcohol and caffeine; without energy drink) and Comparator 3 (with alcohol and energy drink) in people with Perceived Alcohol Intoxication, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The purpose of this study is to determine whether the ingestion of caffeine, Energy Drinks has an effect on perceived alcohol intoxication. Read more about this study
- Who is it for?
- Ages 20 to 26 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Perceived Alcohol Intoxication
- What is being tested?
- Comparator 1 (with alcohol; without caffeine and energy drink), Comparator 2 (with alcohol and caffeine; without energy drink) and Comparator 3 (with alcohol and energy drink)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2011to May 2012
- 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 20 to 26 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers
- Able and willing to comply with the requirements of the study, confirmed by written informed consent
- Aged 20 to 26 years
- Within acceptable range for weight and body mass index (70-85 kg and 21 to 25 kg/m2)
- At least 12-14 years of formal education
- In good general health as determined by medical history and screening investigations (see below)
Show all 14Show fewer
- Taking no regular medication
- No history of psychiatric disorders
- Moderate alcohol consumption (less than 190.4 g/week) according to the Daily Drink questionnaire (Collins et a., 1985)
- "sporadic" users of Energy Drinks (fewer than 10 cans of 250 ml in the last 6 months)
- Confirmation that the general practitioner/primary care physician knows no reason that would prevent their participation
- Similar in social and demographic data, similar quality of life
- similar patterns of use of alcoholic beverages and Energy Drinks as well as quality of life (Martinez et al., 2000)
- similar level of physical activity (physical activity questionnaire) (Baecke et al., 1982)
Who cannot join
- Any condition that the investigator and/or sponsor consider might increase the risk to the volunteer or decrease the chance of obtaining satisfactory data
- Consumed 2>x>4 caffeine-containing drinks/day within 3 months of screening
- Smoked >10 cigarettes/day or equivalent within 3 months of screening
- Consumed more than 190.4 g alcohol per week, or have a history of alcohol or drug abuse or
- Consumed less than one alcoholic drink per week
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna, Deparment of pediatric and adolescent medicine
Vienna, 1090
About this study
Official title: A Double Blind, Randomised, Placebo-controlled, Within-subject Crossover Study to Examine the Possible Effects of Energy Drink Ingestion on Perceived Alcohol Intoxication
The purpose of this study is to determine whether the ingestion of caffeine, Energy Drinks has an effect on perceived alcohol intoxication.
Read the detailed description
In each of the four study periods, subjects will receive one of the four study treatments in a double blind, randomised, manner. The effects of study treatment on alcohol intoxication will be determined by measurement of breath alcohol concentration and subjective effects of intoxication. Safety and tolerability will be monitored by measurement of vital signs, in particular pulse, and review of adverse events.
- Conditions
- Perceived Alcohol Intoxication
- Being tested
- Placebo (without alcohol, caffeine, energy drink), Comparator 1 (with alcohol; without caffeine and energy drink), Comparator 2 (with alcohol and caffeine; without energy drink), Comparator 3 (with alcohol and energy drink)
- Keywords
- energy drinks, alcohol intoxication
- Medical subject headings
- Alcoholic Intoxication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo (without alcohol, caffeine, energy drink)Drug
(carbonated) water (volume equivalent to 46.5 g ethanol (inform of vodka (37.5%)) (carbonated) water (250 ml), artificial fruit juice (21 g/L prepared with (carbonated) water). The final volume of the mixture is 500 mL.
Comparator 1 (with alcohol; without caffeine and energy drink)Drug
Mixture of 46.5 g ethanol (inform of vodka (37.5%)), (carbonated) water 250 mL, artificial fruit juice (21 g/L prepared with (carbonated) water). The final volume of the mixture 500 mL.
Comparator 2 (with alcohol and caffeine; without energy drink)Drug
Mixture of 46.5 g ethanol (inform of vodka (37.5%)), caffeine (80 mg), (carbonated) water (250 ml), artificial fruit juice (21 g/L prepared with (carbonated) water) The final volume of the mixture is 500 mL.
Comparator 3 (with alcohol and energy drink)Drug
Mixture of 46.5 g ethanol (inform of vodka (37.5%)), Red Bull® Energy Drink (250 mL, without flavour mixture to optimize blinding), artificial fruit juice (21 g/L prepared with (carbonated) water).The final volume of the mixture is 500 mL.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo (without alcohol, caffeine, energy drink) |
| Comparator 1 (with alcohol) | Active comparator | Not described Receives: Drug: Comparator 1 (with alcohol; without caffeine and energy drink) |
| Comparator 2 (with alcohol and coffeine) | Active comparator | Not described Receives: Drug: Comparator 2 (with alcohol and caffeine; without energy drink) |
| Comparator 3 (with alcohol and energy drink) | Experimental | Not described Receives: Drug: Comparator 3 (with alcohol and energy drink) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in breath alcohol concentration
Measured: from baseline up to 150 minutes
Changes of subjective effects of intoxication
Measured: from baseline up to 120 minutes
Secondary outcomes (2)
Safety and tolerability
Safety and tolerability will be monitored by measurement of vital signs, in particular pulse, and review of adverse events.
Measured: participants will be followed for the whole testing period of an expected average of 5 hours
Changes in Supine and standing vital signs
Measured: from baseline up to 150 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2011 (estimated)
- Study startJan 2011
- Primary completionMay 2012 (estimated)
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perceived Alcohol IntoxicationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Christoph Aufricht, Univ.Prof.Dr., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350089
- Sponsor's protocol ID
- ED and alcohol intoxication
- Status last verified
- May 2011
- First submitted
- 4 May 2011
- Last updated
- 9 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomised, Placebo-controlled, Within-subject Crossover Study to Examine the Possible Effects of Energy Drink Ingestion on Perceived Alcohol Intoxication
- ClinicalTrials.gov ID
- NCT01350089
- Acronym / sponsor ID
- ED and alcohol intoxication
- Conditions
- Perceived Alcohol Intoxication
- Keywords
- energy drinks, alcohol intoxication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- May 2012 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 9 May 2011 (estimated)
- 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 this study is to determine whether the ingestion of caffeine, Energy Drinks has an effect on perceived alcohol intoxication.
Detailed description
In each of the four study periods, subjects will receive one of the four study treatments in a double blind, randomised, manner. The effects of study treatment on alcohol intoxication will be determined by measurement of breath alcohol concentration and subjective effects of intoxication. Safety and tolerability will be monitored by measurement of vital signs, in particular pulse, and review of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo (without alcohol, caffeine, energy drink) |
| Comparator 1 (with alcohol) | Active comparator | Drug: Comparator 1 (with alcohol; without caffeine and energy drink) |
| Comparator 2 (with alcohol and coffeine) | Active comparator | Drug: Comparator 2 (with alcohol and caffeine; without energy drink) |
| Comparator 3 (with alcohol and energy drink) | Experimental | Drug: Comparator 3 (with alcohol and energy drink) |
Who may qualify
- Ages
- 20 to 26 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Healthy male volunteers
- Able and willing to comply with the requirements of the study, confirmed by written informed consent
- Aged 20 to 26 years
- Within acceptable range for weight and body mass index (70-85 kg and 21 to 25 kg/m2)
- At least 12-14 years of formal education
Key exclusion criteria (5 listed)
- Any condition that the investigator and/or sponsor consider might increase the risk to the volunteer or decrease the chance of obtaining satisfactory data
- Consumed 2>x>4 caffeine-containing drinks/day within 3 months of screening
- Smoked >10 cigarettes/day or equivalent within 3 months of screening
- Consumed more than 190.4 g alcohol per week, or have a history of alcohol or drug abuse or
- Consumed less than one alcoholic drink per week
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 |
|---|---|---|
| Placebo (without alcohol, caffeine, energy drink)(carbonated) water (volume equivalent to 46.5 g ethanol (inform of vodka (37.5%)) (carbonated) water (250 ml), artificial fruit juice (21 g/L prepared with (carbonated) water). The final volume of the mixture is 500 mL. | Drug | Placebo |
| Comparator 1 (with alcohol; without caffeine and energy drink)Mixture of 46.5 g ethanol (inform of vodka (37.5%)), (carbonated) water 250 mL, artificial fruit juice (21 g/L prepared with (carbonated) water). The final volume of the mixture 500 mL. | Drug | Comparator 1 (with alcohol) |
| Comparator 2 (with alcohol and caffeine; without energy drink)Mixture of 46.5 g ethanol (inform of vodka (37.5%)), caffeine (80 mg), (carbonated) water (250 ml), artificial fruit juice (21 g/L prepared with (carbonated) water) The final volume of the mixture is 500 mL. | Drug | Comparator 2 (with alcohol and coffeine) |
| Comparator 3 (with alcohol and energy drink)Mixture of 46.5 g ethanol (inform of vodka (37.5%)), Red Bull® Energy Drink (250 mL, without flavour mixture to optimize blinding), artificial fruit juice (21 g/L prepared with (carbonated) water).The final volume of the mixture is 500 mL. | Drug | Comparator 3 (with alcohol and energy drink) |
Primary outcome
Changes in breath alcohol concentration
Time frame: from baseline up to 150 minutes
Changes of subjective effects of intoxication
Time frame: from baseline up to 120 minutes
2 secondary outcomes
Safety and tolerability
Time frame: participants will be followed for the whole testing period of an expected average of 5 hours
Changes in Supine and standing vital signs
Time frame: from baseline up to 150 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2011.
- Homepage MUViennaLink provided by the sponsor.
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.
Christoph Aufricht, Univ.Prof.Dr. principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparator 1 (with alcohol; without caffeine and energy drink), Comparator 2 (with alcohol and caffeine; without energy drink) and Comparator 3 (with alcohol and energy drink) in people with Perceived Alcohol Intoxication, run by Medical University of Vienna at 1 site in Austria.
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 14 inclusion and 5 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 May 2011. 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 Austria. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in breath alcohol concentration (time frame: from baseline up to 150 minutes). 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?
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 May 2011.