NL-OMON43288
Completed
N/A
Investigation of psychomotor performance to evaluate clinical impairment and pharmacokinetic aspects of methadone and buprenorphine: a double-blind placebo-controlled randomized trial - The acute effects of methadone and buprenorphine on driving
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- cognitief functioneren
- Sponsor
- niversiteit Maastricht
- Enrollment
- 25
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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
Exclusion Criteria
- •\- 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
Outcomes
Primary Outcomes
Not specified
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