intoxication en driving under influence
Conditions
Interventions
All subjects will receive all of the following study treatments: 10 mg d-AMP +
0.8 g/kg alcohol, 10 mg d-AMP + alcohol-free drink, 0.8 g/kg Alcohol + placebo
and placebo + alcohol-free drink in a ra
Sponsors
TNO
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Healthy as assessed by the - health and lifestyle questionnaire (PDRUID F02; in Dutch) - physical examination - results of a standard 12-lead ECG 2. Males/Females aged * 20 and * 40 years at Day 01 of the study 3. Previous experience with the recreational use of alcohol and dexamphetamine or amphetamine derivatives 4. Normal weight and BMI (* 18 and * 28 kg/m2) 5. Having a driving license and two years of driving experience 6. Voluntary participation 7. Having given written informed consent 8. Willing to comply with the study procedures 9. Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years 10. Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned.
Exclusion criteria
Exclusion criteria: 1. Participation in any clinical trial including blood sampling and/or administration of substances up to 6 weeks before Day 01 of this study 2. Having a history of medical or surgical events that may significantly affect the study outcome, including psychiatric disorders, cardiovascular disease and/or hypertension (systolic > 160 mmHg and diastolic > 95 mmHg). 3. History of drug abuse or addiction 4. Using psychotropic medication 5. History of malignant hyperthermia /serotonin syndrome 6. Susceptibility to simulator sickness (subjects will be pretested) 7. Heavy smoking: during the visit at TNO smoking is restricted to one break. 8. Alcohol consumption (> 28 units/week for males and > 21 units/week for females) 9. Pregnant or lactating or wishing to become pregnant in the period of the study 10. Personnel of TNO Defence, Safety and Security, their partner and their first and second degree relatives 11. Not having a general practitioner 12. Not willing to accept information-transfer concerning participation in the study, or information regarding his/her health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected that d-AMP may reduce sedation and impairment of vigilance caused by EtOH, but may potentiate risk-taking behaviour and impaired judgement, when 0.8 g/kg EtOH and 10 mg d-AMP are taken in combination. The combination may also potentiate *tunnel vision* and deficits in divided attention. Effects can be expected on different variables of the driving test. | — |
Countries
Netherlands
Outcome results
None listed