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Invloed van alcohol op aandacht.


- candidate number11125
- NTR NumberNTR3297
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-feb-2012
- Secondary IDs12-3-001 METC
- Public TitleInvloed van alcohol op aandacht.
- Scientific TitleMeasuring the impairment of different doses of alcohol on skills related to car driving.
- ACRONYM
- hypothesisObjective 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.
- Healt Condition(s) or Problem(s) studiedAlcohol, Dose effects
- Inclusion criteria1. Healthy males and females;
2. Aged between 18 and 30 yrs;
3. BMI between 19 and 29 m2/kg;
4. Social drinkers.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2012
- planned closingdate1-sep-2012
- Target number of participants24
- InterventionsSingle 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).
- Primary outcomeDual 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 outcomeA one-hour battery of computerized performance tests assessing alertness, sustained attention, visual orienting, executive attention, attention switching, psychomotor speed, postural balance, working memory.
- TimepointsAcute effects. Performance is assessed within two hours after each dose of alcohol.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. A. Vermeeren
- CONTACT for SCIENTIFIC QUERIESDr. A. Vermeeren
- Sponsor/Initiator University Maastricht (UM)
- Funding
(Source(s) of Monetary or Material Support)
University Maastricht (UM)
- PublicationsN/A
- Brief summaryUse 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.
- Main changes (audit trail)
- RECORD13-feb-2012 - 2-mrt-2012


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