AzTrials
AzTrials

Driving Under the InfluenceCIDANCT04230460

Cannabis Impairment Detection Application (CIDA)

A study testing Cannabis (High% THC) (Inhaled), Cannabis (Very High% THC) (Inhaled) and Alcohol (oral) in people with Driving Under the Influence and Marijuana Intoxication, run by Advanced Brain Monitoring, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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)… Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
What is being tested?
Cannabis (High% THC) (Inhaled), Cannabis (Very High% THC) (Inhaled) and Alcohol (oral)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
124 participants
Where
1 siteUnited States
Study dates
1 Sep 2020to 27 May 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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)]

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Iowa. National Advanced Driving Simulator

    Iowa City, Iowa, 52242

Other trials in United States

About this study

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
Read the 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.

Being tested
Cannabis (THC) (Inhaled) Placebo, Cannabis (High% THC) (Inhaled), Cannabis (Very High% THC) (Inhaled), Alcohol (oral)
Keywords
Marijuana, Cannabis, Alcohol, Driving, DUI, Drinking behavior, Substance Use, Driving Impairment, Drugs, EEG, SDLP
Medical subject headings
Driving Under the Influence, Alcoholic Intoxication, Marijuana Abuse, Drinking Behavior, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cannabis (THC) (Inhaled) PlaceboDrug

    Also called Marihuana, Marijuana

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

  • Cannabis (High% THC) (Inhaled)Drug

    Also called Marihuana, Marijuana

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

  • Cannabis (Very High% THC) (Inhaled)Drug

    Also called Marihuana, Marijuana

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

  • Alcohol (oral)Drug

    Also called Ethanol, Ethyl Alcohol

    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.

Study groups in NCT04230460
Study groupRoleWhat they receive
0% THC/ 0% CBDPlacebo comparatorNot described
Receives: Drug: Cannabis (THC) (Inhaled) Placebo
THC (5-10% [37.5 mg]) / Low CBD (<1% [2.5 mg])ExperimentalNot described
Receives: Drug: Cannabis (High% THC) (Inhaled)
THC (>10% [62.5 mg]) / Low CBD (<1% [2.5 mg])ExperimentalNot described
Receives: Drug: Cannabis (Very High% THC) (Inhaled)
0.065% BACExperimentalNot described
Receives: Drug: Alcohol (oral)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

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

  2. 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.

    Measured: Between -0.7 hours and 8 hours post cannabis administration

  3. ECG Measures

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

    Measured: Between -0.7 hours and 8 hours post cannabis administration

Secondary outcomes (4)

  1. 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.

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

  2. 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.

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

  3. 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.

    Measured: From 0.5 hours to 1.5 hours post cannabis administration

  4. 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.

    Measured: From 0.5 hours to 1.5 hours post cannabis administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2020
  2. Study start1 Sep 2020
  3. Primary completion27 May 2021
  4. Study completion27 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04230460
Sponsor's protocol ID
N44DA-19-1218
Acronym
CIDA
Status last verified
Jul 2021
First submitted
9 Jan 2020
Last updated
12 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified driving and dose data will be made available after analyses are complete.

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.

    PubMed 6525328

Questions about this trial

What is this clinical trial studying?

A study testing Cannabis (High% THC) (Inhaled), Cannabis (Very High% THC) (Inhaled) and Alcohol (oral) in people with Driving Under the Influence and Marijuana Intoxication, run by Advanced Brain Monitoring, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Driving Performance (time frame: Through entire 45-minute drive, 0.5-1.3 hour post cannabis administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04230460, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in