NL-OMON33806CompletedNot Applicable
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
Rijksuniversiteit Groningen0 sites20 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
Investigators
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