HealthyNCT01118364
Effect of Cannabis on Simulated and Actual Driving in Healthy Subjects
A study testing Cannabis and tobacco in people with Healthy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cannabis and tobacco
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- May 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Healthy
- Being tested
- Cannabis, tobacco
- Keywords
- Social circumstances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabisOther
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
tobaccoOther
a cigarette tobacco trade mark "Drum" 45 minutes before simulating or real driving
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Cannabis |
| cigarette without cannabis | Other | a cigarette tobacco trade mark "Drum" Receives: Other: tobacco |
What is being measured
The primary outcome is the main question the study is designed to answer.
Line crossing
Measurement of inappropriate crossing of the limits of track in real or simulated driving
Measured: 1 years
Secondary outcomes (4)
Weaving
Measure of the deviation of the lateral position of the vehicle on the real or simulated road
Measured: 1 years
Evaluation of sleepiness and fatigue
Measured: 1 years
Evaluation of fitness to drive
Measured: 1 years
Evaluation of fitness to drive during work distraction
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2010 (estimated)
- Study startMay 2010
- Primary completionFeb 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01118364
- Sponsor's protocol ID
- 2009-A00940-57
- Other IDs
- 2009/24
- Status last verified
- Aug 2014
- First submitted
- 5 May 2010
- Last updated
- 28 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cannabis on Simulated and Actual Driving in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01118364
- Acronym / sponsor ID
- 2009-A00940-57
- Conditions
- Healthy
- Keywords
- Social circumstances
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 6 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cigarette with cannabis | Experimental | Other: Cannabisa cigarette tobacco trade mark "Drum" with the addition of 250 mg of cannabis resin with 8% of D9THC (20 mg per cigarette) |
| cigarette without cannabis | Other | Other: tobaccoa cigarette tobacco trade mark "Drum" |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabisa 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 | Other | cigarette with cannabis |
| tobaccoa cigarette tobacco trade mark "Drum" 45 minutes before simulating or real driving | Other | cigarette without cannabis |
Primary outcome
Line crossing
Time frame: 1 years
Measurement of inappropriate crossing of the limits of track in real or simulated driving
4 secondary outcomes
Weaving
Time frame: 1 years
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cannabis and tobacco in people with Healthy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Line crossing (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2014.