- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01118364
Effect of Cannabis on Simulated and Actual Driving in Healthy Subjects
27. august 2014 opdateret af: Assistance Publique Hopitaux De Marseille
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.
Studieoversigt
Detaljeret beskrivelse
- 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
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
20
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Marseille, Frankrig
- Assistance Hôpitaux de Marseille
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
25 år til 35 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Han
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: cigarette with cannabis
a cigarette tobacco trade mark "Drum" with the addition of 250 mg of cannabis resin with 8% of D9THC (20 mg per cigarette)
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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
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Andet: cigarette without cannabis
a cigarette tobacco trade mark "Drum"
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a cigarette tobacco trade mark "Drum" 45 minutes before simulating or real driving
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Line crossing
Tidsramme: 1 years
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Measurement of inappropriate crossing of the limits of track in real or simulated driving
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1 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Weaving
Tidsramme: 1 years
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Measure of the deviation of the lateral position of the vehicle on the real or simulated road
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1 years
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Evaluation of sleepiness and fatigue
Tidsramme: 1 years
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1 years
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Evaluation of fitness to drive
Tidsramme: 1 years
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1 years
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Evaluation of fitness to drive during work distraction
Tidsramme: 1 years
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1 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. maj 2010
Primær færdiggørelse (Faktiske)
1. februar 2011
Studieafslutning (Faktiske)
1. december 2011
Datoer for studieregistrering
Først indsendt
5. maj 2010
Først indsendt, der opfyldte QC-kriterier
5. maj 2010
Først opslået (Skøn)
6. maj 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
28. august 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. august 2014
Sidst verificeret
1. august 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2009-A00940-57
- 2009/24 (Registry Identifier: internal reference)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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