Investigation of psychomotor performance to evaluate clinical impairment and pharmacokinetic aspects of methadone and buprenorphine: a double-blind placebo-controlled randomized trial

Maastricht University0 个研究点开始时间: 2016年9月7日最近更新: 2016年10月24日

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•- Healthy males or females, in the opinion of the medical supervisor, based on a physical examination, medical history, vital signs, electrocardiogram, and the results of blood chemistry and hematology tests, and urinalysis
•- Aged between 23 and 50 years (inclusive)
•- BMI between 19 and 29 m2/kg (inclusive)
•- Possession of a valid driving license for 4 years or more
•- Driving experience of at least 5000 km per year on average
•- Good sleepers
•- Subjects should sign an Informed Consent Form
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 25
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Sleep disorders such as insomnia and narcolepsy
•- History of or current drug or alcohol abuse
•- Current use of psycho-active medication, and inability to stay abstinent during the study
•- Excessive alcohol use, defined as drinking more than 21 glasses of alcohol per week
•- Excessive caffeine use, defined as drinking 5 or more cups of coffee per day
•- Smoking more than 10 cigarettes per day
•- History or presence of drug/alcohol abuse, including experience with heroin, methadone and buprenorphine
•- Intake of any opioid within 3 months before the study
•- Use of any drug that is considered to influence the test drugs, including trade herbal products
•- History of severe allergic disease
•- History of significant mental, cardiovascular, renal or hepatic disorder, or other significant disease as judged by the investigator
•- Positive pre-session urine sample of any of the following substances: ethanol, benzodiazepines, tetrahydrocannabinol, cocaine, amphetamines or opioids
•- Poor metabolism due to CYP2B6 polymorphism
•- Prolonged QT-interval (history of or presence at screening)
•- Use of any drug that is known to inhibit or induce CYP3A4 activity
•- Women who are pregnant or breastfeeding
•- No use of a reliable contraceptive

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