Study of the Relationship Between Dose-concentration-effect of Delta-9-tetrahydrocannabinol (THC) and the Ability to Drive in Chronic or Occasional Cannabis Users

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Dronabinol

Criteria

Inclusion criteria:

• Healthy volunteer of male gender from 18 to 25 years

• Normal medical examination

• Driving license owner

• BMI between 18.5 and 25

• moderate tobacco consumption

• moderate consumption of coffee, tea, cola (≤ 225mg caffeine per day)

• Cannabis user for at least 1 year

• Occasional (1-2 joints per week) or chronic (1-2 joints per day) cannabis consumers

• Availability during the study

• Signed consent

Exclusion criteria:

• Participation in another clinical study

• Having taken any psychotropic medication in the past one month

• Having taken any narcotic (alcohol, psychotropic drugs, other narcotics) other than THC in the past 3 days (negative urinary test at inclusion)

• Alcohol blood level positive at inclusion

• Excessive alcohol consumption (AUDIT score > 7)

• Dependence, present or past, to any psychotropic product (alcohol, psychoactive drugs, other narcotic)

• Depression

• Sleep disorders

• Any psychiatric history, including psychosis

• Deprived of their liberty by judicial or administrative decision

• Lack of medical insurance

• Professional use of motorized vehicles