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ID
Source
Brief title
Health condition
Healthy volunteers, sedation, driving performance, dronabinol
Sponsors and support
Intervention
Outcome measures
Primary outcome
Standard deviation of lateral position in driving task.
Secondary outcome
1. Highway driving;
2. Car following;
3. Field sobriety tests;
4. Subjective measures.
Background summary
Dronabinol is medicinal cannabis used for chronic pain, anorexia in AIDS and antiemesis in chemotherapy treated cancer patients. Cannabis is known to have impairing effect on driving performance. Since dronabinol is given orally, the effects on driving are unknow.
Study objective
Dronabinol impairs driving performance in light cannabis users, but not in heavy users, because of tolerance to the impairing effects.
Study design
3 testconditions on different days with 1 week in between.
Intervention
Dronabinol 10 and 20 mg, placebo.
Dept of Neuropsychology & Psychopharmacology, Faculty of Psychology and Neuroscience,
P.O. Box 616
J.G. Ramaekers
Maastricht 6200 MD
The Netherlands
+31 (0)43 3881951
J.Ramaekers@psychology.unimaas.nl
Dept of Neuropsychology & Psychopharmacology, Faculty of Psychology and Neuroscience,
P.O. Box 616
J.G. Ramaekers
Maastricht 6200 MD
The Netherlands
+31 (0)43 3881951
J.Ramaekers@psychology.unimaas.nl
Inclusion criteria
1. Aged between 18 and 45 years;
2. Healthy volunteers;
3. BMI between 18 and 28;
4. Able to give a written informed consent;
5. Experience with cannabis use;
6. Valid driving license.
Exclusion criteria
1. History of drug abuse/addiction or psychiatric condition;
2. Pregnancy or lactation;
3. Cardiovascular abnormalities;
4. Hypertension;
5. Susceptibility of simulator sickness;
6. Allergy to sesame oil.
Design
Recruitment
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL1793 |
| NTR-old | NTR1903 |
| Other | : P50 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |