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

Completed

Conditions: gevolgen voor rijvaardigheid
Influence of MDMA/ alcohol on driving performance

Registration Number: NL-OMON33806

Lead Sponsor: Rijksuniversiteit Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

Experience with the use of MDMA (at least 5 times in the past 12 months)
Experience with the use of alcohol (<2 or > 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

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Study parameters/endpoints: Performance on the driving- and driving related<br /><br>tasks.<br /><br><br /><br>Main study parameter/endpoint:Performance on the driving- and driving related<br /><br>tasks.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters/endpoints: Saliva, whole blood, blood plasma and<br /><br>blood spot analyses for drug levels and breathe analyser measures of the<br /><br>alcohol level, results from the questionnaires </p><br>