Study of the effects of smoked cannabis consumption on performance on a driving simulator and reaction time. The study aims to explore the relationship between concentrations of cannabis in the blood, driving performance and reaction time.
This study will examine: * The relationship between THC blood levels and driving performance measured on a York Driving simulator * The relationship between THC blood levels and reaction times as measured on the psychomotor vigilance test (PVT) * the pharmacokinetics of THC in occasional and chronic cannabis consumers * Determine the minimum blood concentration level of THC and 11-OH-THC, below which no effect of cannabis is observed * Determine whether the polymorphism of CYP2C9 (\* 3) is associated with the AUC, Cmax, and higher THC T1/2 * Determine if the polymorphism of CYP2C9 (\* 3) is associated with different pharmacodynamic effects at a given THC level on performance measured by driving simulation
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
37
Smoked THC containing cigarettes. Randomly allocated dosage 30mg, 10mg et placebo. Both chronic and occasional cannabis consuming volunteers will be allocated to smoking a cigarette containing (1) no THC (placebo), (2) a joint containing 1% THC (10 mg THC, i.e. low-dose) and (3) a joint containing 3% (30 mg THC) mixed with 1 g tobacco. Each cigarette will be followed by 24 hours testing in laboratory conditions. Each period is separated by 7 days (3 testing periods over 3 weeks). Each volunteer will undergo performance testing (driving simulator and PVT) before administration of the substance (T0). Blood samples and repeat performance testing will be carried out at 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours.
Raymond Poincare Hospital
Garches, France
Ability to drive a motor vehicle measured using a driving simulator
The association between THC blood concentrations and driving performances as measured by deviations from the centre of the road and variations of speed at 0h, 1h, 2h, 4h, 6h, 8h, 12h and 24 h after smoking.
Time frame: 0h, 1h, 2h, 4h, 6h, 8h, 12h and 24 h
Psychomotor Vigilance Test (PVT) measures
The association between THC blood concentration and impaired reaction time on PVT measured sequentially over 24 hours
Time frame: 0h, 1h, 2h, 4h, 6h, 8h, 12h et 24h
THC pharmacokinetics of occasional and chronic users over 24 hours
THC pharmacokinetics parameters (AUC, T1/2, CMAX) of occasional and chronic users over 24 hours will be modelled using a population nonlinear mixed approach.
Time frame: 24 hours
24 hoursTHC pharmacokinetics (AUC, T1 / 2, CMAX) and its relationships with genotype CYP2C9 * 3
24 hoursTHC pharmacokinetics (AUC, T1 / 2, CMAX) and its relationships with genotype CYP2C9 \* 3
Time frame: 24 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.