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Effect of Cannabis on Simulated and Actual Driving in Healthy Subjects

Primary Purpose

Healthy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cannabis
tobacco
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Healthy focused on measuring Social circumstances

Eligibility Criteria

25 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Assistance Hôpitaux de Marseille

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

cigarette with cannabis

cigarette without cannabis

Arm Description

a cigarette tobacco trade mark "Drum" with the addition of 250 mg of cannabis resin with 8% of D9THC (20 mg per cigarette)

a cigarette tobacco trade mark "Drum"

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Weaving
Measure of the deviation of the lateral position of the vehicle on the real or simulated road
Evaluation of sleepiness and fatigue
Evaluation of fitness to drive
Evaluation of fitness to drive during work distraction

Full Information

First Posted
May 5, 2010
Last Updated
August 27, 2014
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT01118364
Brief Title
Effect of Cannabis on Simulated and Actual Driving in Healthy Subjects
Official Title
Effect of Cannabis on Simulated and Actual Driving in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Social circumstances

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cigarette with cannabis
Arm Type
Experimental
Arm Description
a cigarette tobacco trade mark "Drum" with the addition of 250 mg of cannabis resin with 8% of D9THC (20 mg per cigarette)
Arm Title
cigarette without cannabis
Arm Type
Other
Arm Description
a cigarette tobacco trade mark "Drum"
Intervention Type
Other
Intervention Name(s)
Cannabis
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
tobacco
Intervention Description
a cigarette tobacco trade mark "Drum" 45 minutes before simulating or real driving
Primary Outcome Measure Information:
Title
Line crossing
Description
Measurement of inappropriate crossing of the limits of track in real or simulated driving
Time Frame
1 years
Secondary Outcome Measure Information:
Title
Weaving
Description
Measure of the deviation of the lateral position of the vehicle on the real or simulated road
Time Frame
1 years
Title
Evaluation of sleepiness and fatigue
Time Frame
1 years
Title
Evaluation of fitness to drive
Time Frame
1 years
Title
Evaluation of fitness to drive during work distraction
Time Frame
1 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Assistance Hôpitaux de Marseille
City
Marseille
Country
France

12. IPD Sharing Statement

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Effect of Cannabis on Simulated and Actual Driving in Healthy Subjects

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