- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01118364
Effect of Cannabis on Simulated and Actual Driving in Healthy Subjects
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
- 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
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Marseille, France
- Assistance Hôpitaux de Marseille
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: cigarette with cannabis
a cigarette tobacco trade mark "Drum" with the addition of 250 mg of cannabis resin with 8% of D9THC (20 mg per cigarette)
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a cigarette tobacco trade mark "Drum" with the addition of 250 mg of cannabis resin with 8% of D9THC (20 mg per cigarette)45 minutes before simulating or real driving
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Autre: cigarette without cannabis
a cigarette tobacco trade mark "Drum"
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a cigarette tobacco trade mark "Drum" 45 minutes before simulating or real driving
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Line crossing
Délai: 1 years
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Measurement of inappropriate crossing of the limits of track in real or simulated driving
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1 years
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Weaving
Délai: 1 years
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Measure of the deviation of the lateral position of the vehicle on the real or simulated road
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1 years
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Evaluation of sleepiness and fatigue
Délai: 1 years
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1 years
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Evaluation of fitness to drive
Délai: 1 years
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1 years
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Evaluation of fitness to drive during work distraction
Délai: 1 years
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1 years
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Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2009-A00940-57
- 2009/24 (Identificateur de registre: internal reference)
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