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 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•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

•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

发起方

Rijksuniversiteit Groningen