No registrations found.
ID
Source
Health condition
dose effects of alcohol
Sponsors and support
Intervention
Outcome measures
Primary outcome
Dual task performance using a divided attention task. The task combines psychomotor tracking test with peripheral visual search task. Dependent measures are speed and accuracy of responses in both subtasks
Secondary outcome
A one-hour battery of computerized performance tests assessing alertness, sustained attention, visual orienting, executive attention, attention switching, psychomotor speed, postural balance, working memory.
Background summary
Use of psychoactive medication is associated with increased risks of motor vehicle accidents. New psychoactive medications should therefore be screened early in development for their potential to impair driving related skills. There is no consensus however on the performance test(s) that can be recommended for such purposes. The purpose of this study is therefore to compare the sensitivity of a number of available tests to drug-induced impairment by comparing the dose-effects of alcohol on performance. Twenty-four healthy male and female volunteers will participate in this 4-way double blind crossover design. Alcohol treatment consists of pure ethanol (mixed orange juice) in gender and weight adjusted doses to reach blood alcohol concentrations of 0.0, 0.2, 0.5 and 0.8 mg/ml. Performance tests will be conducted within two hours after each dose of alcohol.
Study objective
Objective of this study is to assess the sensitivity of performance in a number of widely used tests for measuring driver impairment to the dose-effects of alcohol.
Study design
Acute effects. Performance is assessed within two hours after each dose of alcohol.
Intervention
Single oral doses of ethanol mixed with orange juice sufficient to raise Blood Alcohol Concentrations to approximately 0.2, 0.5 and 0.8 mg/ml, and placebo (orange juice only).
Maastricht University<br>
PO Box 616
A. Vermeeren
Maastricht 6200 MD
The Netherlands
+31 (0)43 3881952
a.vermeeren@maastrichtuniversity.nl
Maastricht University<br>
PO Box 616
A. Vermeeren
Maastricht 6200 MD
The Netherlands
+31 (0)43 3881952
a.vermeeren@maastrichtuniversity.nl
Inclusion criteria
1. Healthy males and females;
2. Aged between 18 and 30 yrs;
3. BMI between 19 and 29 m2/kg;
4. Social drinkers.
Exclusion criteria
1. History or mental illness;
2. Current physical illness;
3. Use of medication or drugs;
4. Drinking less than 3 glasses alcohol per week or more than 21 glasses of alcohol per week;
5. Execessive use of caffeine or nicotine.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3153 |
| NTR-old | NTR3297 |
| Other | METC : 12-3-001 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |