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Completed

NCT Number: 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.

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Key information

Conditions

Age range

25 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Hôpitaux de Marseille

Marseille, France

About this study

  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cannabis

Other

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

Tobacco

Other

a cigarette tobacco trade mark "Drum" 45 minutes before simulating or real driving

Primary outcomes

  1. Line crossing

    Time frame: 1 years

    Measurement of inappropriate crossing of the limits of track in real or simulated driving

Secondary outcomes

  1. Weaving

    Time frame: 1 years

    Measure of the deviation of the lateral position of the vehicle on the real or simulated road

  2. Evaluation of sleepiness and fatigue

    Time frame: 1 years

  3. Evaluation of fitness to drive

    Time frame: 1 years

  4. Evaluation of fitness to drive during work distraction

    Time frame: 1 years

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 6, 2010
Registry last updated
Aug 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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