Effect of Cannabis on Simulated and Actual Driving in Healthy Subjects

NCT01118364 | Completed

• 2 other identifiers: 2009-A00940-572009/24
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Social circumstances

Outcome Measures

Primary Outcomes (1)

• Line crossing

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

  1 years

Secondary Outcomes (4)

• Weaving

  1 years

• Evaluation of sleepiness and fatigue

  1 years

• Evaluation of fitness to drive

  1 years

• Evaluation of fitness to drive during work distraction

  1 years

Study Arms (2)

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

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

cigarette with cannabis

tobacco OTHER

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

cigarette without cannabis

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Hôpitaux de Marseille

Marseille, France

Location

MeSH Terms

Interventions

nabiximols; Tobacco Products

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 5, 2010
• First Posted: May 6, 2010
• Study Start: May 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 28, 2014

Record last verified: 2014-08

Locations

FR (1)