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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A00245-40 | Other Identifier | IDRCB |
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Study of the effects of smoked cannabis consumption on performance on a driving simulator and reaction time. The study aims to explore the relationship between concentrations of cannabis in the blood, driving performance and reaction time.
This study will examine:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental |
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| Sequence 2 | Experimental |
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| Sequence 3 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabis (THC) in cigarettes of 30mg, 10mg and placebo | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Ability to drive a motor vehicle measured using a driving simulator | 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. | 0h, 1h, 2h, 4h, 6h, 8h, 12h and 24 h |
| Measure | Description | Time Frame |
|---|---|---|
| Psychomotor Vigilance Test (PVT) measures | The association between THC blood concentration and impaired reaction time on PVT measured sequentially over 24 hours | 0h, 1h, 2h, 4h, 6h, 8h, 12h et 24h |
| THC pharmacokinetics of occasional and chronic users over 24 hours |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Hartley, MD | Sleep Disorders Unit - Raymond Poincaré Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Raymond Poincare Hospital | Garches | 92380 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38074719 | Derived | Hartley S, Simon N, Cardozo B, Larabi IA, Alvarez JC. Can inhaled cannabis users accurately evaluate impaired driving ability? A randomized controlled trial. Front Public Health. 2023 Nov 22;11:1234765. doi: 10.3389/fpubh.2023.1234765. eCollection 2023. | |
| 33386756 | Derived | 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. |
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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 |
| 24 hoursTHC pharmacokinetics (AUC, T1 / 2, CMAX) and its relationships with genotype CYP2C9 * 3 | 24 hoursTHC pharmacokinetics (AUC, T1 / 2, CMAX) and its relationships with genotype CYP2C9 * 3 | 24 hours |
| 30872375 | Derived | 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. |
| ID | Term |
|---|---|
| C587251 | nabiximols |
| D013759 | Dronabinol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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