Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06595576
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
Cannabis Edibles and Simulated Driving
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Dose-dependent Effects of Cannabis Edibles on Simulated Driving Performance
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this human laboratory experiment is to determine the acute and residual effects of a range of doses of orally administered cannabis edibles on driving simulator performance in people who use cannabis recreationally Four conditions will be tested placebo low dose medium dose and high dose Driving performance will be tested objectively using a driving simulator during a number of pre-programmed driving scenarios The investigators will test the hypothesis that driving performance on a high-fidelity driving simulator will decrease with increasing doses of cannabis Secondary objectives will
Determine the acute and residual 24 hour cognitive behavioural and physiological effects of a range of doses of orally administered cannabis edibles on subjective effects cognitive tests verbal memory and mood
Examine how the concentration of THC in blood and oral fluids correlates with driving simulator performance as well as cognitive behavioural and physiological measures Cannabinoid levels in blood urine and oral fluids will be measured at baseline and over a 5 hour period following drug exposure The investigators will examine the relationship between cannabinoid levels and performance measures in this time frame
Explore potential biomarkers of acute exposure to cannabis edibles by analyzing the following circulating cell-free mtDNA ccf-mtDNA endocannabinoids and metabolic biomarkers
Determine the acute and residual 24 hour cognitive behavioural and physiological effects of a range of doses of orally administered cannabis edibles on subjective effects cognitive tests verbal memory and mood
Examine how the concentration of THC in blood and oral fluids correlates with driving simulator performance as well as cognitive behavioural and physiological measures Cannabinoid levels in blood urine and oral fluids will be measured at baseline and over a 5 hour period following drug exposure The investigators will examine the relationship between cannabinoid levels and performance measures in this time frame
Explore potential biomarkers of acute exposure to cannabis edibles by analyzing the following circulating cell-free mtDNA ccf-mtDNA endocannabinoids and metabolic biomarkers
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None