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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.
- 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
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research
Assistance Hôpitaux de Marseille
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Assistance Publique Hopitaux De Marseille
Published on BioPortfolio: 2014-08-27T03:13:53-0400
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Tobacco used to the detriment of a person's health or social functioning. Tobacco dependence is included.
The aggregate business enterprise of agriculture, manufacture, and distribution related to tobacco and tobacco-derived products.
Use of TOBACCO (Nicotiana tabacum L) and TOBACCO PRODUCTS.
Items used to aid in ending a TOBACCO habit.
Inhaling and exhaling the smoke of tobacco or something similar to tobacco.
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