To assess the effects of dronabinol 10 and 20 mg on driving performance in healthy volunteers
Conditions
Interventions
Trade Name: Marinol
Product Name: Marinol
Product Code: 1972-08-3
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: DRONABINOL
CAS Number: 03/08/1972
Concentration unit: mg milligram(s)
Concentr
Sponsors
European Commission
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Netherlands
Outcome results
None listed