Effects of dronabinol (Marinol(R)) on actual driving, simulated driving and Standardized Field Sobriety Test
- Conditions
- To assess the effects of dronabinol 10 and 20 mg on driving performance in healthy volunteers
- Registration Number
- EUCTR2009-014402-33-NL
- Lead Sponsor
- European Commission
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
experience with cannabis use
good physical health and free from psychotropic medication
Body Mass Index between 18 and 28
valid driving license
able to give written informed consent
aged between 18 and 45 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
history of drug abuse or addiction
pregnancy or lactation
cardiovascular abnormalities
excessive drinking
hypertension
history of or current psychiatric disorder
susceptibility to simulator sickness
allergy to sesame oil
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess differential effects of dronabinol in heavy and light cannabis users on driving performance.;Secondary Objective: To assess the capability of the field sobriety tests to differentiate between impaired and unimpaired drivers.;Primary end point(s): Standard Deviation of Lateral Position in actual driving task
- Secondary Outcome Measures
Name Time Method