Effect of Cannabis on Simulated and Actual Driving in Healthy Subjects

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2011 by Assistance Publique Hopitaux De Marseille.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Assistance Publique Hopitaux De Marseille

ClinicalTrials.gov Identifier:

NCT01118364

First received: May 5, 2010

Last updated: January 26, 2011

Last verified: January 2011

History of Changes

Purpose

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.

Condition	Intervention
Healthy	Other: Cannabis Other: tobacco

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Health Services Research
Official Title:	Effect of Cannabis on Simulated and Actual Driving in Healthy Subjects

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:

Line crossing [ Time Frame: 1 years ]
Measurement of inappropriate crossing of the limits of track in real or simulated driving

Secondary Outcome Measures:

Weaving [ Time Frame: 1 years ]
Measure of the deviation of the lateral position of the vehicle on the real or simulated road
Evaluation of sleepiness and fatigue [ Time Frame: 1 years ]
Evaluation of fitness to drive [ Time Frame: 1 years ]
Evaluation of fitness to drive during work distraction [ Time Frame: 1 years ]

Estimated Enrollment:	20
Study Start Date:	May 2010
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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)	Other: Cannabis 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
cigarette without cannabis a cigarette tobacco trade mark "Drum"	Other: tobacco a cigarette tobacco trade mark "Drum" 45 minutes before simulating or real driving

Detailed 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

Eligibility

Ages Eligible for Study:	25 Years to 35 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01118364

Contacts

Contact: Olivier Blin

+33491384646

olivier.blin@ap-hm.fr

Locations

France
Assistance Hôpitaux de Marseille	Recruiting
Marseille, France
Contact: Olivier Blin

Sponsors and Collaborators

Assistance Publique Hopitaux De Marseille

More Information

No publications provided

Responsible Party:	Assistance Publique Hôpitaux de Marseille, direction de la recherche
ClinicalTrials.gov Identifier:	NCT01118364 History of Changes
Other Study ID Numbers:	2009-A00940-57, 2009/24
Study First Received:	May 5, 2010
Last Updated:	January 26, 2011
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Assistance Publique Hopitaux De Marseille:

Social circumstances

ClinicalTrials.gov processed this record on May 16, 2013

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