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| Name | Class |
|---|---|
| University of Iowa | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0% THC/ 0% CBD | Placebo Comparator |
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| THC (5-10% [37.5 mg]) / Low CBD (<1% [2.5 mg]) | Experimental |
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| THC (>10% [62.5 mg]) / Low CBD (<1% [2.5 mg]) | Experimental |
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| 0.065% BAC | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabis (THC) (Inhaled) Placebo | Drug | Cannabis vapor is produced from 500 mg of dried plant material (placebo) (0% THC). Participants will inhale ad libitum over 10 minutes. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chris Berka, B.S | Advanced Brain Monitoring | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa. National Advanced Driving Simulator | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 6525328 | Background | 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. |
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De-identified driving and dose data will be made available after analyses are complete.
After analysis of data (May 2021).
Individual requests to the PI.
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| ID | Term |
|---|---|
| D000066448 | Driving Under the Influence |
| D000435 | Alcoholic Intoxication |
| D002189 | Marijuana Abuse |
| D004327 | Drinking Behavior |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D000066479 | Criminal Behavior |
| D001519 | Behavior |
| D003617 | Dangerous Behavior |
| D019973 | Alcohol-Related Disorders |
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| ID | Term |
|---|---|
| C587251 | nabiximols |
| D013759 | Dronabinol |
| D001239 | Inhalation |
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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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).
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University of Iowa: Triple (Participant, Investigator, Outcomes Assessor) blind
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| Cannabis (High% THC) (Inhaled) | Drug | Cannabis vapor is produced from 500 mg of dried plant material (7.5% THC). Participants will inhale ad libitum over 10 minutes. |
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| Cannabis (Very High% THC) (Inhaled) | Drug | Cannabis vapor is produced from 500 mg of dried plant material (12.5% THC). Participants will inhale ad libitum over 10 minutes. |
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| Alcohol (oral) | Drug | 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. |
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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 |
| D064419 |
| Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015656 |
| Respiratory Mechanics |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D000438 | Alcohols |