Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2026-01-17 @ 4:52 AM
Study NCT ID:
NCT02061020
Status:
COMPLETED
Last Update Posted:
2016-06-09
First Post:
2013-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Relationship Between Dose-concentration-effect of Delta-9-tetrahydrocannabinol (THC) and the Ability to Drive in Chronic or Occasional Cannabis Users
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Pilot Study of the Relationship Between Dose-concentration-effect of Delta-9-tetrahydrocannabinol and the Ability to Drive in Chronic or Occasional Cannabis Users
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIGICANN
Brief Summary:
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.
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
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2013-A00245-40 | OTHER | IDRCB | View |