The acute effects of methadone and buprenorphine on driving
- Conditions
- oneTherapeutic area: Not possible to specify
- Registration Number
- EUCTR2016-001512-38-NL
- Lead Sponsor
- Maastricht University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to compare the acute effects of single doses of methadone (5 and 10 mg) and buprenorphine (0.2 and 0.4 mg) with placebo on driving performance and cognition. ;Secondary Objective: Secondary objective is to study the pharmacokinetics of methadone and buprenorphine in blood and oral fluid.;Primary end point(s): The main study parameter is the Standard Deviation of Lateral Position (SDLP in cm) in the highway driving test, as well as drug concentrations in blood and oral fluid.;Timepoint(s) of evaluation of this end point: Evaluation of this endpoint will take place once datacollection is completed
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Secondary parameters will be accuracy and/or speed in the following tests:<br>?- Psychomotor Vigilance Test (PVT)<br>?- Critical tracking test (CTT)<br>?- Divided Attention Test (DAT)<br>?- Useful Field of View (UFOV)<br>?- Digit Symbol Substitution Test (DSST)<br>?- Postural Balance test (PBT)<br>?- Vienna Test System Determination Test (DT);Timepoint(s) of evaluation of this end point: Evaluation of this endpoint will take place once datacollection is completed