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Cannabis Impairment Detection Application (CIDA) (CIDA)

Primary Purpose

Driving Under the Influence, Marijuana Intoxication, Alcohol Intoxication

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cannabis (THC) (Inhaled) Placebo

Cannabis (High% THC) (Inhaled)

Cannabis (Very High% THC) (Inhaled)

Alcohol (oral)

About this trial

This is an interventional basic science trial for Driving Under the Influence focused on measuring Marijuana, Cannabis, Alcohol, Driving, DUI, Drinking behavior, Substance Use, Driving Impairment, Drugs, EEG, SDLP

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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)]

Sites / Locations

University of Iowa. National Advanced Driving Simulator

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

0% THC/ 0% CBD

THC (5-10% [37.5 mg]) / Low CBD (<1% [2.5 mg])

THC (>10% [62.5 mg]) / Low CBD (<1% [2.5 mg])

0.065% BAC

Arm Description

Outcomes

Primary Outcome Measures

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).

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.

ECG Measures

Changes in heart rate as measured by electrocardiogram (ECG) (R-R interval). ECG is sampled at 256 Hz.

Secondary Outcome Measures

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.

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.

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.

Event-Related EEG Latency

Full Information

NCT ID

NCT04230460

First Posted

January 9, 2020

Last Updated

July 8, 2021

Sponsor

Advanced Brain Monitoring, Inc.

Collaborators

University of Iowa

1. Study Identification

Unique Protocol Identification Number

NCT04230460

Brief Title

Cannabis Impairment Detection Application (CIDA)

Acronym

CIDA

Official Title

Cannabis Impairment Detection Application (CIDA)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

September 1, 2020 (Actual)

Primary Completion Date

May 27, 2021 (Actual)

Study Completion Date

May 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Advanced Brain Monitoring, Inc.

Collaborators

University of Iowa

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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: Further understand the effects of acute cannabis intoxication on driving performance in a driving simulator 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Driving Under the Influence, Marijuana Intoxication, Alcohol Intoxication

Keywords

Marijuana, Cannabis, Alcohol, Driving, DUI, Drinking behavior, Substance Use, Driving Impairment, Drugs, EEG, SDLP

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

The University of Iowa study is a counter-balanced dose-response protocol where all participants will receive all three doses of marijuana (plus alcohol if they qualify).

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

University of Iowa: Triple (Participant, Investigator, Outcomes Assessor) blind

Allocation

Randomized

Enrollment

124 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0% THC/ 0% CBD

Arm Type

Placebo Comparator

Arm Title

THC (5-10% [37.5 mg]) / Low CBD (<1% [2.5 mg])

Arm Type

Experimental

Arm Title

THC (>10% [62.5 mg]) / Low CBD (<1% [2.5 mg])

Arm Type

Experimental

Arm Title

0.065% BAC

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Cannabis (THC) (Inhaled) Placebo

Other Intervention Name(s)

Marihuana, Marijuana

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cannabis (High% THC) (Inhaled)

Other Intervention Name(s)

Marihuana, Marijuana

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cannabis (Very High% THC) (Inhaled)

Other Intervention Name(s)

Marihuana, Marijuana

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Alcohol (oral)

Other Intervention Name(s)

Ethanol, Ethyl Alcohol

Intervention Description

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.

Primary Outcome Measure Information:

Title

Driving Performance

Description

Time Frame

Through entire 45-minute drive, 0.5-1.3 hour post cannabis administration

Title

EEG Measures

Description

Time Frame

Between -0.7 hours and 8 hours post cannabis administration

Title

ECG Measures

Description

Changes in heart rate as measured by electrocardiogram (ECG) (R-R interval). ECG is sampled at 256 Hz.

Time Frame

Between -0.7 hours and 8 hours post cannabis administration

Secondary Outcome Measure Information:

Title

THC Concentration in Plasma Sample

Description

Measurement of THC concentration levels in plasma over the course of each visit compared to that of the other visits.

Time Frame

-0.7 hour, 0.25 hour, 1.1 hour, 2 hour, 3 hour, 4.5 hour, 6 hour, 8 hour post cannabis administration

Title

THC Concentration Levels in Whole Blood

Description

Measurement of THC concentration levels in whole blood over the course of each visit compared to that of the other visits.

Time Frame

-0.7 hour, 0.25 hour, 1.1 hour, 2 hour, 3 hour, 4.5 hour, 6 hour, 8 hour post cannabis administration

Title

Event-Related EEG Amplitude

Description

Time Frame

From 0.5 hours to 1.5 hours post cannabis administration

Title

Event-Related EEG Latency

Description

Time Frame

From 0.5 hours to 1.5 hours post cannabis administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)]

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chris Berka, B.S

Organizational Affiliation

Advanced Brain Monitoring

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Iowa. National Advanced Driving Simulator

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Citations:

PubMed Identifier

6525328

Citation

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.

Results Reference

background

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Cannabis Impairment Detection Application (CIDA)

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