Effect of Cannabis on Simulated and Actual Driving in Healthy Subjects

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Effect of Cannabis on Simulated and Actual Driving in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Other: Cannabis
* Other: tobacco


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cigarette with cannabis<br>a cigarette tobacco trade mark Drum with the addition of 250 mg of cannabis resin with 8% of D9THC (20 mg per cigarette) | Other: Cannabis<br>* 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<br>|
| Other: cigarette without cannabis<br>a cigarette tobacco trade mark Drum | Other: tobacco<br>* a cigarette tobacco trade mark Drum 45 minutes before simulating or real driving<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Line crossing | Measurement of inappropriate crossing of the limits of track in real or simulated driving | 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weaving | Measure of the deviation of the lateral position of the vehicle on the real or simulated road | 1 years | 
| Evaluation of sleepiness and fatigue |  | 1 years | 
| Evaluation of fitness to drive |  | 1 years | 
| Evaluation of fitness to drive during work distraction |  | 1 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Social circumstances