Effect of Cannabis on Simulated and Actual Driving in Healthy Subjects
Summary
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.
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
Study Design
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research
Conditions
Healthy
Intervention
Cannabis, tobacco
Location
Assistance Hôpitaux de Marseille
Marseille
France
Status
Not yet recruiting
Source
Assistance Publique Hopitaux De Marseille
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01118364
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Tobacco Use Disorder
Tobacco used to the detriment of a person's health or social functioning. Tobacco dependence is included.
Tobacco Industry
The aggregate business enterprise of agriculture, manufacture, and distribution related to tobacco and tobacco-derived products.
Smoking
Inhaling and exhaling the smoke of tobacco or something similar to tobacco.
Tobacco, Smokeless
The powdered leaves of Nicotiana tabacum which are either inhaled through the nose, chewed, or stored in cheek pouches. It includes any product of tobacco that is not smoked.
Tobacco Use Cessation
Cessation of the habit of using tobacco products for smoking or chewing, including the use of snuff.
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