Cannabis Impairment Detection Application (CIDA)

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

Conditions

• Driving Under the Influence
• Marijuana Intoxication
• Alcohol Intoxication

Interventions

DRUG

Cannabis (THC) (Inhaled) Placebo

Cannabis vapor is produced from 500 mg of dried plant material (placebo) (0% THC). Participants will inhale ad libitum over 10 minutes.

DRUG

Cannabis (High% THC) (Inhaled)

Cannabis vapor is produced from 500 mg of dried plant material (7.5% THC). Participants will inhale ad libitum over 10 minutes.

DRUG

Cannabis (Very High% THC) (Inhaled)

Cannabis vapor is produced from 500 mg of dried plant material (12.5% THC). Participants will inhale ad libitum over 10 minutes.

DRUG

Alcohol (oral)

Subjects will be dosed to achieve a 0.05% Blood Alcohol Concentration (BAC), so the amount of alcohol consumed will be calculated to produce a peak BAC of 0.065%. Subjects will be served three equal-sized drinks, 10-minutes apart, and be instructed to pace each drink evenly over the 10-minute period.

Sponsors & Collaborators

• University of Iowa

  collaborator OTHER

• Advanced Brain Monitoring, Inc.

  lead INDUSTRY

Principal Investigators

• Chris Berka, B.S · Advanced Brain Monitoring

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-09-01

Primary Completion

2021-05-27

Completion

2021-05-27

Countries

• United States

Study Locations