Cannabis Impairment Detection Application (CIDA)
CIDA
1 other identifier
interventional
124
1 country
1
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:
- 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2020
CompletedFirst Posted
Study publicly available on registry
January 18, 2020
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 27, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 27, 2021
CompletedJuly 12, 2021
July 1, 2021
9 months
January 9, 2020
July 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (4)
THC Concentration in Plasma Sample
-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
-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
From 0.5 hours to 1.5 hours post cannabis administration
Event-Related EEG Latency
From 0.5 hours to 1.5 hours post cannabis administration
Study Arms (4)
0% THC/ 0% CBD
PLACEBO COMPARATORTHC (5-10% [37.5 mg]) / Low CBD (<1% [2.5 mg])
EXPERIMENTALTHC (>10% [62.5 mg]) / Low CBD (<1% [2.5 mg])
EXPERIMENTAL0.065% BAC
EXPERIMENTALInterventions
Cannabis vapor is produced from 500 mg of dried plant material (placebo) (0% THC). Participants will inhale ad libitum over 10 minutes.
Cannabis vapor is produced from 500 mg of dried plant material (7.5% THC). Participants will inhale ad libitum over 10 minutes.
Cannabis vapor is produced from 500 mg of dried plant material (12.5% THC). Participants will inhale ad libitum over 10 minutes.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Advanced Brain Monitoring, Inc.lead
- University of Iowacollaborator
Study Sites (1)
University of Iowa. National Advanced Driving Simulator
Iowa City, Iowa, 52242, United States
Related Publications (1)
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.
PMID: 6525328BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chris Berka, B.S
Advanced Brain Monitoring
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- University of Iowa: Triple (Participant, Investigator, Outcomes Assessor) blind
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2020
First Posted
January 18, 2020
Study Start
September 1, 2020
Primary Completion
May 27, 2021
Study Completion
May 27, 2021
Last Updated
July 12, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- After analysis of data (May 2021).
- Access Criteria
- Individual requests to the PI.
De-identified driving and dose data will be made available after analyses are complete.