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 is to study the pharmacokinetics…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
cognitief functioneren
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Secondary objective is to study the pharmacokinetics of methadone and
buprenorphine in blood and oral fluid.
Background summary
Methadone and buprenorphine are used in maintenance therapy of persons with
heroin addiction, but are also widely used as analgesics. Both methadone and
buprenorphine are known to have CNS (central nervous system) effects which may
be deleterious to safe driving. However, it is known that tolerance may develop
to these deleterious effects. Recent epidemiological studies suggest an
increased risk of traffic accidents for methadone maintenance treatment
patients (MMP) and buprenorphine maintenance treatment patients (BMP). Persons
outside maintenance treatment are regularly observed among drivers suspected
for drugged driving testing positive for methadone or buprenorphine. Few
studies on performance of healthy volunteers after administration of single
dose of methadone or buprenorphine have been performed.
Study 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 is to study
the pharmacokinetics of methadone and buprenorphine in blood and oral fluid.
Study design
A five-way, single-blind, randomized, placebo-controlled, double-dummy,
cross-over design to compare the acute effects of two single doses of methadone
(5 and 10 mg) and buprenorphine (0.2 and 0.4 mg) with placebo on actual driving
performance and a range of cognitive tests.
Intervention
n.a.
Study burden and risks
Volunteers* health will be assessed before treatment during a screening visit
(1 hour, including an ECG test and assessment of a medical history
questionnaire). Eligible participants will visit the research unit on seven
more occasions. The first 2 sessions includes familiarization and practice of
the driving and performance tests (approximately 2 hours per session).
Subsequently, they will visit five times for intervention and testing
(approximately 7 hours for each condition). The treatments are single doses of
methadone 5 mg, methadone 10 mg, buprenorphine 0.2 mg, buprenorphine 0.4 mg and
placebo. At the end of intervention days participants will be transported home
by taxi. Total time spent by the participants will be approximately 39 hours. A
total of four blood samples will be collected during each test day. During the
experiment participants must refrain from consuming caffeine on the test days
and alcohol intake from 24 hours prior to test days.
Lovisenberggata 6
Oslo 0456
NL
Lovisenberggata 6
Oslo 0456
NL
Listed location countries
Age
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
- 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-001512-38-NL |
| CCMO | NL57504.068.16 |
| Other | nog niet beschikbaar |