Effect of Cannabis on Simulated and Actual Driving in Healthy Subjects

Public Assistance-Hospitals of Marseille (AP-HM)

Status

Completed

Conditions

Healthy

Treatments

Other: Cannabis

Other: tobacco

Study type

Interventional

Funder types

Other

Identifiers

NCT01118364

2009/24 (Registry Identifier)

2009-A00940-57

Details and patient eligibility

About

Assess the effect of cigarette smoking of tobacco with or without addition of resin cannabis on driving performance in healthy volunteers in simulated driving in Marseille and Toulouse, and in real world driving to Bordeaux.

Multicenter Study of phase 1, randomized, double-blind, cross plan, carried out in healthy male volunteers.

Full description

To compare performance data driving with the data self-assessed on the ability to drive, and the level of sleepiness and fatigue
To measure the effects of distractive task on driving performance, consisting of a conversation with co-driver of the real or simulated vehicle (a series of difficult questions involving reflection)
To validate the (known) effects of cannabis
To adapt equipment and standardize methods for the pharmacological studies evaluating other types of substances having an impact on driving (antihistamines, antidepressants, antiparkinsonian ...) and other populations of subjects (men versus women, young versus elderly, healthy versus sick ...)
To compare data obtained under conditions of simulated driving and actual driving situation, under identical experimental conditions (volunteers, narcotic substance, experimental) and measure the degree of ecological validity of the simulation of driving

Enrollment

20 patients

Sex

Male

Ages

25 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Weight +/- 10% of ideal weight
Tobacco smoker moderate
Having already smoked of the cannabis (less 1 time per month)
Not consuming in a way exaggerated by some coffee, tea or cola
Not having acute or chronic pathologies
Normal electrocardiogram
Not taking a drug interfering with the study
Not presenting disorder of sleeping
Having a driving license for at least 3 years and driving more 3000 km per year
Normal acuteness or corrected visual acuteness and normal vision of colors
Reachable and available during the study
No nausea or vomit during using of a driving simulator
Having a national insurance scheme
Volunteer

Exclusion criteria

Women
Weight deviating of 10% of ideal weight
Consuming moreover 5 cup of caffeine drinks
Drinking alcohol regularly
Acute or chronic pathologies interfering with the study
Abnormal electrocardiogram
Asthmatic
Dependence present or spent in a psychotropic substance
Presenting an anxious or depressive syndrome
Circadian typology (Horne et Ostberg)
Positive control in the cannabis in urines the day of the balance assessment of inclusion
Positive control in alcohol the day of the balance assessment of inclusion
Participating in another clinical study
Having collected an upper total amount of compensations allowances
Deprived of freedom further to a court or administrative order
Risk of not observance
Duration average of sleep of 3 nights previous every session lower than 80 % of the average duration of sleep which the volunteer thinks of needing to be in shape