The objective of the present study is to determine the sensitivity of the tests used in different fields of expertise for the dose-effects of alcohol.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
n.v.t. Het betreft gezonde vrijwilligers die alleen alcohol toegediend krijgen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary dependent variable is tracking error in the divided attention test
(DAT).
Secondary outcome
Average reaction time of the divided attention task (DAT), Tracking accuracy at
the critical tracking test (CTT), number of digits processed at the Digit
Symbol Substitution Test, mean reaction time at the Psychomotor Vigilance Test
(PVT), reaction time and accuracy at the Concept Shifting Test (CST), number of
recalled sequences at the Digit Span Test, mean reaction time and accuracy at
the Attention Network Test (ANT), and the AP95 (area of the 95% confidence
ellipse enclosing the center of pressure) at a balance test.
Background summary
Many people use medicinal and illicit drugs that can have detrimental effects
on performance such as driving. There is an increasing demand for screening
various drugs and doses for their impairing potential and associated risks. One
of the problems, however, is that there is no consensus on the objective tests
to be used. Various research fields use different tests.
Study objective
The objective of the present study is to determine the sensitivity of the tests
used in different fields of expertise for the dose-effects of alcohol.
Study design
This study will be conducted according to a randomized, double-blind, placebo
controlled, crossover design.
Intervention
Treatments are three doses of alcohol sufficient to raise blood alcohol
concentrations to 0.2, 0.5, and 0.8 mg/ml BAC, and placebo (BAC 0.0 mg/ml).
Study burden and risks
Volunteers* health will be ensured before treatment during a brief visit (15
minutes) using a medical history questionnaire, and routine analysis of blood
and urine samples. Eligible subjects will visit the unit on three more
occasions. Firstly, they will visit the unit for familiarization and practice
of the performance tests (approximately 2 hours). Subsequently, they will visit
the unit twice for treatment and testing (approximately 5,5 hours per test
day). Treatment is alcohol in low or moderate doses. At the end of testing on
treatment days subjects will be transported home by taxi. Total time spent by
the subjects will be approximately 13 hours.
Postbus 616
6200 MD Maastricht
NL
Postbus 616
6200 MD Maastricht
NL
Listed location countries
Age
Inclusion criteria
Healthy
Age 18 till 30 (inclusive)
BMI between 19 and 29
Exclusion criteria
Smoking more than 7 cigarettes per week
Drinking more than 6 cups of caffein and/or xanthine containing products per day
Drinking less than 3 or more than 21 glasses of alcohol per week
Use of drugs
For women: pregnancy
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 |
|---|---|
| CCMO | NL39218.068.12 |
| Other | Nog niet beschikbaar |