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Effect of pain medication on driving performance.


- candidate number6076
- NTR NumberNTR1903
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-jul-2009
- Secondary IDsP50 
- Public TitleEffect of pain medication on driving performance.
- Scientific TitleEffect of dronabinol on actual driving, simulated driving and the Standardized Field Sobriety Test.
- ACRONYMN/A
- hypothesisDronabinol impairs driving performance in light cannabis users, but not in heavy users, because of tolerance to the impairing effects.
- Healt Condition(s) or Problem(s) studiedHealthy subjects, Sedation, Driving performance, Dronabinol
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-sep-2009
- planned closingdate1-mrt-2010
- Target number of participants24
- InterventionsDronabinol 10 and 20 mg, placebo.
- Primary outcomeStandard deviation of lateral position in driving task.
- Secondary outcome1. Highway driving;
2. Car following;
3. Field sobriety tests;
4. Subjective measures.
- Timepoints3 testconditions on different days with 1 week in between.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. J.G. Ramaekers
- CONTACT for SCIENTIFIC QUERIESDr. J.G. Ramaekers
- Sponsor/Initiator University Maastricht (UM)
- Funding
(Source(s) of Monetary or Material Support)
European Commission
- PublicationsN/A
- Brief summaryDronabinol 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.
- Main changes (audit trail)
- RECORD9-jul-2009 - 10-okt-2009


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