Investigation of psychomotor performance to evaluate clinical impairment and pharmacokinetic aspects of methadone and buprenorphine: a double-blind placebo-controlled randomized trial
- Conditions
- cognitief functionerennot applicable
- Registration Number
- NL-OMON43288
- Lead Sponsor
- niversiteit Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
- 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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of this study is to compare the acute effects of single<br /><br>doses of methadone (5 and 10 mg) and buprenorphine (0.2 and 0.4 mg) with<br /><br>placebo on driving performance and cognition. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary objective is to study the pharmacokinetics of methadone and<br /><br>buprenorphine in blood and oral fluid.</p><br>