Cannabis Impairment Detection Application (CIDA) (CIDA)

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

Study Overview

• Status: Completed
• Conditions: Alcohol Intoxication; Driving Under the Influence; Marijuana Intoxication
• Intervention / Treatment: Drug: Cannabis (THC) (Inhaled) Placebo; Drug: Cannabis (High% THC) (Inhaled); Drug: Cannabis (Very High% THC) (Inhaled); Drug: Alcohol (oral)

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.

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men and women 18 to 50 years of age in good health (21 to 50 for alcohol arm)
• Valid US driver's license and have been licensed driver for two years
• Restrictions on driver's license limited to vision correction only
• Drive at least three times per week
• Must be able to drive without special or non-standard equipment
• Must be able to attend three morning daytime study visits lasting approximately 5 to 6 hours
• Must be willing to abstain from alcohol use in the day prior to their study appointments
• Must be willing to abstain from use of their own cannabis while enrolled in the study
• Live within 1-hour driving radius of National Advanced Driving Simulator (NADS)
• Must currently use cannabis at least once every three months and no more than four times per week (must be current user)
• Peripheral veins suitable for venipuncture
• Blood pressure within clinically normal range
• If invited to complete alcohol arm: Must be considered a light or moderate drinker according to Quantity-Frequency-Variability Scale (QFV) or, if a heavy drinker, not drink more than 1-2 times a week and not have a modal quantity of 5-6 drinks

Exclusion Criteria:

• Females who are pregnant or test positive for pregnancy or are breastfeeding
• Any known sleep disorders, or family history of sleep disorders
• Any neurological or pulmonary disorders (or taking medications for such)
• Any psychiatric disorder (or taking medications for such)
• Any eating disorders
• Recent (past 5 years) head injury, or older head injury with current symptoms
• High blood pressure, Heart disease, diabetes, or history of stroke or taking medications to treat
• Any known behavioral or attention disorder (or taking medications for such)
• Untreated/Untreatable vision or auditory issues (because testing currently requires both senses)
• Excessive tobacco use (more than 10 cigarettes a day)
• Excessive caffeine use (5 or more servings per day)
• Excessive alcohol (20 or more drinks per week)
• Donation of 450 mL or more of blood in the two weeks preceding study drug administration
• Regular use of pain medications other than over-the-counter
• Any medication use that causes drowsiness or is contraindicated for driving
• Use of prescription drugs not prescribed to them or illicit drugs other than cannabis
• Propensity to motion sickness (more than 2-3 episodes where intensity is moderate or above)
• History of substance abuse or substance addiction
• Currently participating in or interested in drug abuse treatment, or participation in a program in past 60 days
• Current cannabis use disorder or alcohol use disorder [as determined by scores on the Cannabis Use Disorder Identification Test (CUDIT) and Alcohol Use Disorder Identification Test (AUDIT)]

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 0% THC/ 0% CBD	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.; Other Names: Marijuana; Marihuana
Experimental: THC (5-10% [37.5 mg]) / Low CBD (<1% [2.5 mg])	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.; Other Names: Marijuana; Marihuana
Experimental: THC (>10% [62.5 mg]) / Low CBD (<1% [2.5 mg])	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.; Other Names: Marijuana; Marihuana
Experimental: 0.065% BAC	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.; Other Names: Ethanol; Ethyl Alcohol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Driving Performance	Measured by standard deviation of lane position (SDLP, a gold standard metric of driving performance, O'Hanlon, 1984). This will provide a measure of general performance based on how well the driver maintains a consistent lane position. SDLP has been shown to be among the most important performance measures for evaluating the effects of psychophysiological changes due to impairment from medication use on driving performance (O'Hanlon, 1984).	Through entire 45-minute drive, 0.5-1.3 hour post cannabis administration
EEG Measures	Changes in electroencephalogram (EEG) spectral power measures for Delta, Theta, Alpha, Beta, Gamma bands. EEG is sampled at 256 Hertz (Hz) and power spectral measures are calculated in one-second time intervals.	Between -0.7 hours and 8 hours post cannabis administration
ECG Measures	Changes in heart rate as measured by electrocardiogram (ECG) (R-R interval). ECG is sampled at 256 Hz.	Between -0.7 hours and 8 hours post cannabis administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
THC Concentration in Plasma Sample	Measurement of THC concentration levels in plasma over the course of each visit compared to that of the other visits.	-0.7 hour, 0.25 hour, 1.1 hour, 2 hour, 3 hour, 4.5 hour, 6 hour, 8 hour post cannabis administration
THC Concentration Levels in Whole Blood	Measurement of THC concentration levels in whole blood over the course of each visit compared to that of the other visits.	-0.7 hour, 0.25 hour, 1.1 hour, 2 hour, 3 hour, 4.5 hour, 6 hour, 8 hour post cannabis administration
Event-Related EEG Amplitude	For each neurocognitive task, EEG will be recorded concurrently. There is a processing pipeline for measuring event-related potentials. This processing pipeline involves pre-processing, artifact removal, and averaging EEG evoked potentials in order to derive amplitude in microvolts.	From 0.5 hours to 1.5 hours post cannabis administration
Event-Related EEG Latency	For each neurocognitive task, EEG will be recorded concurrently. There is a processing pipeline for measuring event-related potentials. This processing pipeline involves pre-processing, artifact removal, and averaging EEG evoked potentials in order to derive latency in milliseconds.	From 0.5 hours to 1.5 hours post cannabis administration

Collaborators and Investigators

• Sponsor: Advanced Brain Monitoring, Inc.
• Collaborators: University of Iowa
• Investigators: Principal Investigator: Chris Berka, B.S, Advanced Brain Monitoring

Publications and helpful links

General Publications

• O'Hanlon JF. Driving performance under the influence of drugs: rationale for, and application of, a new test. Br J Clin Pharmacol. 1984;18 Suppl 1(Suppl 1):121S-129S. doi: 10.1111/j.1365-2125.1984.tb02590.x.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): May 27, 2021
• Study Completion (Actual): May 27, 2021

Study Registration Dates

• First Submitted: January 9, 2020
• First Submitted That Met QC Criteria: January 14, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): July 12, 2021
• Last Update Submitted That Met QC Criteria: July 8, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Driving; EEG; Alcohol; Substance Use; Cannabis; Marijuana; Driving Impairment; Drugs; DUI; Drinking behavior; SDLP
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Marijuana Abuse; Alcoholic Intoxication; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Ethanol
• Other Study ID Numbers: N44DA-19-1218

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified driving and dose data will be made available after analyses are complete.
• IPD Sharing Time Frame: After analysis of data (May 2021).
• IPD Sharing Access Criteria: Individual requests to the PI.
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No