Effects of alcohol (0.5 *) and MDMA (100 mg) on (simulated) driving performance, driving related performance and traffic safety

Effects of alcohol (0.5 *) and MDMA (100 mg) on (simulated) driving performance, driving related performance and traffic safety - MDMA , alcohol and simulated driving performance

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON33806

Enrollment

Registered

2009-11-25

Start date

2010-04-05

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gevolgen voor rijvaardigheid Influence of MDMA/ alcohol on driving performance

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Experience with the use of MDMA (at least 5 times in the past 12 months) Experience with the use of alcohol ( 20 alcoholic consumptions a week) Free from psychotropic medication Good physical health as determined by examination and laboratory analysis Absence of any major medical, endocrine and neurological condition Normal weight, body mass index (weight/length2) between 18 and 28 kg/m2 Valid driving license Written Informed Consent

Exclusion criteria

Exclusion criteria: History of drug abuse or addiction as determined by examination Pregnancy, lactation or wishing to become pregnant in the period of the study Cardiovascular abnormalities as assessed by standard ECG Excessive drinking (> 20 alcoholic consumptions a week) Hypertension (diastolic> 100; systolic> 170) Current or history of psychiatric disorder Participation in any clinical trial including blood sampling and/or administration of substances up to 6 weeks before Day 01 of this study History of malignant hyperthermia /serotonin syndrome Susceptibility to simulator sickness (subjects will be pre-tested) Heavy smoking: during the visit smoking is restricted to breaks. Not having a general practitioner 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
Study parameters/endpoints: Performance on the driving- and driving related tasks. Main study parameter/endpoint:Performance on the driving- and driving related tasks.	—

Secondary

Measure	Time frame
Secondary study parameters/endpoints: Saliva, whole blood, blood plasma and blood spot analyses for drug levels and breathe analyser measures of the alcohol level, results from the questionnaires	—

Countries

Netherlands

Outcome results