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
  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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014