Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 5:43 PM
Study NCT ID:
NCT04230460
Status:
COMPLETED
Last Update Posted:
2021-07-12
First Post:
2020-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cannabis Impairment Detection Application (CIDA)
Sponsor:
Advanced Brain Monitoring, Inc.
Organization:
Study Overview
Official Title:
Cannabis Impairment Detection Application (CIDA)
Status:
COMPLETED
Status Verified Date:
2021-07
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:
CIDA
Brief Summary:
Subjects will participate in a 4-visit study protocol in which they will be asked to complete a set of computerized tasks and a 45-minute simulated drive in a driving simulator. Subjects will be administered marijuana of varying pre-determined concentrations of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) during 3 of the visits and alcohol during one of the visits. Throughout the duration of each visit, brain activity will be measured noninvasively using an electroencephalogram (EEG) headset.
The purpose of this study is to:
1. Further understand the effects of acute cannabis intoxication on driving performance in a driving simulator
2. Develop and refine brain-based biomarkers of impairment due to acute cannabis intoxication
The purpose of this study is to:
1. Further understand the effects of acute cannabis intoxication on driving performance in a driving simulator
2. Develop and refine brain-based biomarkers of impairment due to acute cannabis intoxication
Detailed Description:
At the University of Iowa, subjects who currently use cannabis recreationally (\> once a month but \< 5 times a week) will be recruited. They will then undergo a screening visit in which consent is obtained, questionnaires are given, and a physical exam is administered. They will then be scheduled for their next 3 (or 4 if participating in the alcohol arm), which will be at least one week apart. At each visit, in counter-balanced manner, subjects will be administered 500 mg of either placebo Marijuana (trace amounts of THC), high THC marijuana (7.5%), or very high THC marijuana (12.5%). All marijuana will be inhaled ad libitum via a Volcano® Digit vaporizer. Additionally, a subset of subjects will be asked to complete a fourth study visit that administers alcohol in place of cannabis. As subjects complete the third study visit and meet criteria for the alcohol arm, they will be invited to participate in the fourth study visit until eighteen subjects complete the study's alcohol arm. After drug administration, subjects will be asked to complete a set of computerized neurocognitive tasks (1 hour), followed by a simulated drive (45 minutes).
Throughout the duration of each visit, EEG will be collected. EEG is a non-invasive method of recording the electrical activity of the brain. Additionally, blood draws will be taken at pre-determined time points.
Finally, subjects will be monitored until the drug effects have subsided sufficiently to ensure it is safe to transport them home. Subjects will be transported home.
Throughout the duration of each visit, EEG will be collected. EEG is a non-invasive method of recording the electrical activity of the brain. Additionally, blood draws will be taken at pre-determined time points.
Finally, subjects will be monitored until the drug effects have subsided sufficiently to ensure it is safe to transport them home. Subjects will be transported home.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: