Effect of Cannabis on Simulated and Actual Driving in Hea... | NCT01118364

Studies
Effect of Cannabis on Simulated and Actual Driving in Healthy Subjects

NCT01118364

Sponsor

Assistance Publique Hopitaux De Marseille

Status

Completed

Last Update Posted

Aug 28, 2014Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Cannabis
tobacco

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2009/24	Registry Identifier	internal reference

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Feb 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

May 5, 2010

First Submission Date that Met QC Criteria

May 5, 2010

First Posted Date

May 6, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 27, 2014

Last Update Posted Date

Aug 28, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cigarette with cannabis	Experimental	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
cigarette without cannabis	Other	a cigarette tobacco trade mark "Drum"	Other: tobacco

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
C587251	nabiximols
D062789	Tobacco Products

ID	Term
D000074602	Smoking Devices
D008420	Manufactured Materials
D013676	Technology, Industry, and Agriculture