| - candidate number | 6076 |
| - NTR Number | NTR1903 |
| - ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| - Date ISRCTN created | |
| - date ISRCTN requested | |
| - Date Registered NTR | 9-jul-2009 |
| - Secondary IDs | P50 |
| - Public Title | Effect of pain medication on driving performance. |
| - Scientific Title | Effect of dronabinol on actual driving, simulated driving and the Standardized Field Sobriety Test. |
| - ACRONYM | N/A |
| - hypothesis | Dronabinol 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) studied | Healthy subjects, Sedation, Driving performance, Dronabinol |
| - 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. |
| - mec approval received | no |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Placebo |
| - group | Crossover |
| - Type | Single arm |
| - Studytype | intervention |
| - planned startdate | 1-sep-2009 |
| - planned closingdate | 1-mrt-2010 |
| - Target number of participants | 24 |
| - Interventions | Dronabinol 10 and 20 mg, placebo. |
| - 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. |
| - Timepoints | 3 testconditions on different days with 1 week in between. |
| - Trial web site | N/A |
| - status | planned |
| - CONTACT FOR PUBLIC QUERIES | Dr. J.G. Ramaekers |
| - CONTACT for SCIENTIFIC QUERIES | Dr. J.G. Ramaekers |
| - Sponsor/Initiator | University Maastricht (UM) |
| - Funding (Source(s) of Monetary or Material Support) | European Commission |
| - Publications | N/A |
| - Brief 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. |
| - Main changes (audit trail) | |
| - RECORD | 9-jul-2009 - 10-okt-2009 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl