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Cannabis Impairment Detection Application (CIDA)

2020-01-22 12:12:52 | BioPortfolio

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

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.

Study Design

Conditions

Driving Under the Influence

Intervention

Cannabis (THC) (Inhaled) Placebo, Cannabis (High% THC) (Inhaled), Cannabis (Very High% THC) (Inhaled), Alcohol (oral)

Location

University of Iowa. National Advanced Driving Simulator
Iowa City
Iowa
United States
52242

Status

Not yet recruiting

Source

Advanced Brain Monitoring, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2020-01-22T12:12:52-0500

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Medical and Biotech [MESH] Definitions

A physiologically inactive constituent of Cannabis sativa L.

Compound isolated from Cannabis sativa extract.

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A plant family of the order Urticales, subclass Hamamelidae, class Magnoliopsida. It is most notable for the members, Cannabis and Hops.

Product of the CANNABIS plant, CANNABINOIDS, or synthetic derivatives thereof, used in the treatment of a wide range of clinical symptoms.

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