Study of the Relationship Between Dose-concentration-effect of Delta-9-tetrahydrocannabinol (THC) and the Ability to Drive in Chronic or Occasional Cannabis Users (VIGICANN)
Pilot Study of the Relationship Between Dose-concentration-effect of Delta-9-tetrahydrocannabinol and the Ability to Drive in Chronic or Occasional Cannabis Users
Study Overview
Status
Intervention / Treatment
Detailed Description
This study will examine:
- The relationship between THC blood levels and driving performance measured on a York Driving simulator
- The relationship between THC blood levels and reaction times as measured on the psychomotor vigilance test (PVT)
- the pharmacokinetics of THC in occasional and chronic cannabis consumers
- Determine the minimum blood concentration level of THC and 11-OH-THC, below which no effect of cannabis is observed
- Determine whether the polymorphism of CYP2C9 (* 3) is associated with the AUC, Cmax, and higher THC T1/2
- Determine if the polymorphism of CYP2C9 (* 3) is associated with different pharmacodynamic effects at a given THC level on performance measured by driving simulation
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Garches, France, 92380
- Raymond Poincaré Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- Healthy volunteer of male gender from 18 to 25 years
- Normal medical examination
- Driving license owner
- BMI between 18.5 and 25
- moderate tobacco consumption
- moderate consumption of coffee, tea, cola (≤ 225mg caffeine per day)
- Cannabis user for at least 1 year
- Occasional (1-2 joints per week) or chronic (1-2 joints per day) cannabis consumers
- Availability during the study
- Signed consent
Exclusion criteria:
- Participation in another clinical study
- Having taken any psychotropic medication in the past one month
- Having taken any narcotic (alcohol, psychotropic drugs, other narcotics) other than THC in the past 3 days (negative urinary test at inclusion)
- Alcohol blood level positive at inclusion
- Excessive alcohol consumption (AUDIT score > 7)
- Dependence, present or past, to any psychotropic product (alcohol, psychoactive drugs, other narcotic)
- Depression
- Sleep disorders
- Any psychiatric history, including psychosis
- Deprived of their liberty by judicial or administrative decision
- Lack of medical insurance
- Professional use of motorized vehicles
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sequence 1
|
Smoked THC containing cigarettes. Randomly allocated dosage 30mg, 10mg et placebo. Both chronic and occasional cannabis consuming volunteers will be allocated to smoking a cigarette containing (1) no THC (placebo), (2) a joint containing 1% THC (10 mg THC, i.e. low-dose) and (3) a joint containing 3% (30 mg THC) mixed with 1 g tobacco. Each cigarette will be followed by 24 hours testing in laboratory conditions. Each period is separated by 7 days (3 testing periods over 3 weeks). Each volunteer will undergo performance testing (driving simulator and PVT) before administration of the substance (T0). Blood samples and repeat performance testing will be carried out at 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours. |
|
Experimental: Sequence 2
|
Smoked THC containing cigarettes. Randomly allocated dosage 30mg, 10mg et placebo. Both chronic and occasional cannabis consuming volunteers will be allocated to smoking a cigarette containing (1) no THC (placebo), (2) a joint containing 1% THC (10 mg THC, i.e. low-dose) and (3) a joint containing 3% (30 mg THC) mixed with 1 g tobacco. Each cigarette will be followed by 24 hours testing in laboratory conditions. Each period is separated by 7 days (3 testing periods over 3 weeks). Each volunteer will undergo performance testing (driving simulator and PVT) before administration of the substance (T0). Blood samples and repeat performance testing will be carried out at 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours. |
|
Experimental: Sequence 3
|
Smoked THC containing cigarettes. Randomly allocated dosage 30mg, 10mg et placebo. Both chronic and occasional cannabis consuming volunteers will be allocated to smoking a cigarette containing (1) no THC (placebo), (2) a joint containing 1% THC (10 mg THC, i.e. low-dose) and (3) a joint containing 3% (30 mg THC) mixed with 1 g tobacco. Each cigarette will be followed by 24 hours testing in laboratory conditions. Each period is separated by 7 days (3 testing periods over 3 weeks). Each volunteer will undergo performance testing (driving simulator and PVT) before administration of the substance (T0). Blood samples and repeat performance testing will be carried out at 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ability to drive a motor vehicle measured using a driving simulator
Time Frame: 0h, 1h, 2h, 4h, 6h, 8h, 12h and 24 h
|
The association between THC blood concentrations and driving performances as measured by deviations from the centre of the road and variations of speed at 0h, 1h, 2h, 4h, 6h, 8h, 12h and 24 h after smoking.
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0h, 1h, 2h, 4h, 6h, 8h, 12h and 24 h
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychomotor Vigilance Test (PVT) measures
Time Frame: 0h, 1h, 2h, 4h, 6h, 8h, 12h et 24h
|
The association between THC blood concentration and impaired reaction time on PVT measured sequentially over 24 hours
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0h, 1h, 2h, 4h, 6h, 8h, 12h et 24h
|
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THC pharmacokinetics of occasional and chronic users over 24 hours
Time Frame: 24 hours
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THC pharmacokinetics parameters (AUC, T1/2, CMAX) of occasional and chronic users over 24 hours will be modelled using a population nonlinear mixed approach.
|
24 hours
|
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24 hoursTHC pharmacokinetics (AUC, T1 / 2, CMAX) and its relationships with genotype CYP2C9 * 3
Time Frame: 24 hours
|
24 hoursTHC pharmacokinetics (AUC, T1 / 2, CMAX) and its relationships with genotype CYP2C9 * 3
|
24 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sarah Hartley, MD, Sleep Disorders Unit - Raymond Poincaré Hospital
Publications and helpful links
General Publications
- Alvarez JC, Hartley S, Etting I, Ribot M, Derridj-Ait-Younes N, Verstuyft C, Larabi IA, Simon N. Population pharmacokinetic model of blood THC and its metabolites in chronic and occasional cannabis users and relationship with on-site oral fluid testing. Br J Clin Pharmacol. 2021 Aug;87(8):3139-3149. doi: 10.1111/bcp.14724. Epub 2021 Jan 12.
- Hartley S, Simon N, Larabi A, Vaugier I, Barbot F, Quera-Salva MA, Alvarez JC. Effect of Smoked Cannabis on Vigilance and Accident Risk Using Simulated Driving in Occasional and Chronic Users and the Pharmacokinetic-Pharmacodynamic Relationship. Clin Chem. 2019 May;65(5):684-693. doi: 10.1373/clinchem.2018.299727. Epub 2019 Mar 14.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AOR12144 / P111114
- 2013-A00245-40 (Other Identifier: IDRCB)
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