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

Maastricht University0 sitesSeptember 7, 2016

Overview

No summary available.

Registry

who.int

Start Date

September 7, 2016

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\- 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

•\- 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