Perceived Alcohol Intoxication Clinical Trial
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
| Verified date | May 2011 |
| Source | Medical University of Vienna |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Austria: Ethikkommission |
| Study type | Interventional |
The purpose of this study is to determine whether the ingestion of caffeine, Energy Drinks has an effect on perceived alcohol intoxication.
| Status | Active, not recruiting |
| Enrollment | 52 |
| Est. completion date | May 2012 |
| Est. primary completion date | May 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 20 Years to 26 Years |
| Eligibility |
Inclusion Criteria: - 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) - 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) Exclusion Criteria: - 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 |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Austria | Medical University of Vienna, Deparment of pediatric and adolescent medicine | Vienna |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of Vienna |
Austria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Changes in breath alcohol concentration | from baseline up to 150 minutes | No | |
| Primary | Changes of subjective effects of intoxication | from baseline up to 120 minutes | No | |
| Secondary | Safety and tolerability | Safety and tolerability will be monitored by measurement of vital signs, in particular pulse, and review of adverse events. | participants will be followed for the whole testing period of an expected average of 5 hours | No |
| Secondary | Changes in Supine and standing vital signs | from baseline up to 150 minutes | No |