niet van toepassing niet van toepassing
Conditions
Interventions
Vaporized Bedrocan, Bedrolite and matched placebo cannabis (equivalent to 13.75
mg THC and CBD).
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Occasional cannabis users (>10 lifetime exposures and 3000 km/yr) * Written Informed Consent
Exclusion criteria
Exclusion criteria: * History of drug abuse (other than the use of cannabis) or addiction (determined by the medical questionnaire, drug questionnaire and medical examination) * Pregnancy or lactation (pregnancy test, if needed) * Hypertension (diastolic> 90; systolic> 140) * Current or history of psychiatric disorder (determined by the medical questionnaire and medical examination) * Liver dysfunction * Use of medications that may impact upon driving ability (e.g. mood stabilisers, sedatives) * Any serious prior adverse response to cannabis * History of cardiac dysfunctions (e.g. arrhythmia, ischemic heart disease) * QT syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Driving performance will be assessed using the on-road driving test. Outcome measures will include standard deviation of lateral position (SDLP), speed (MS) and standard deviation of speed (SDSP). | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Cognitive performance as assessed using the Divided Attention Task (DAT), Digit Symbol Substitution Task (DSST), Paced Auditory Serial Addition Task (PASAT), Tower of London (TOL) task; (2) Subjective drug effects and confidence in driving ability as measured by a series of Visual Analog Scales (VAS); Cannabis effects on anxiety as measured by the State Trait Anxiety Inventory (STAI) and an emotional Stroop task, (3) Plasma concentrations of THC, 11-OH-THC, THCCOOH and CBD. | — |
Countries
Netherlands
Outcome results
None listed