Occasional (1-2 Joints Per Week) and Chronic (1-2 Joints Per Day) Cannabis Users Clinical Trial
Official title:
Pilot Study of the Relationship Between Dose-concentration-effect of Delta-9-tetrahydrocannabinol and the Ability to Drive in Chronic or Occasional Cannabis Users
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
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment