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| Name | Class |
|---|---|
| National Advanced Driving Simulator | OTHER |
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Subjects will participate in a 2-visit study protocol in which they will be administered cannabis of pre-determined concentrations and asked to complete a simulated drive in a driving simulator. Subjects will be scanned on two SpotLight-THC (Alpha and Beta iterations) devices and peripheral venous whole blood will be collected from subjects for analysis on up to four occasions on each visit.
The purpose of the investigation will be to determine whether the SpotLight-THC device is a reliable measure of THC impairment at the roadside, with an objective to identify a unique blood analyte architecture for THC impairment using near infrared light and machine learning.
At the University of Iowa, subjects who currently use cannabis recreationally will be recruited. They will then undergo a screening visit in which consent is obtained, questionnaires are given, a physical exam is conducted and subjects will use the driving simulator to assess propensity to sickness and to familiarize them with the simulation. They will then be scheduled for their next visit. At the second visit, subjects will be administered 5-10% THC. A series of baseline tests, including a test requiring a blood sample will be administered upon arrival. After drug administration, subjects will be asked to complete a set of verbal recall questions followed by three simulated driving trials, completing 7 non-invasive SpotLight-19 scans (20 seconds x 2) and 3 blood samples throughout the visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baseline followed by 5-10% THC Validation | Experimental |
| |
| Baseline followed by 5-10% THC Verification | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabis(THC) inhaled | Drug | Cannabis vapor is produced from 500mg, approximately 5-10% High dose bulk cannabis plant material, 30-37.5 mg THC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Acute Subjective Response to Cannabis Score | The total score of the true responses (true/false scale, minimum score is 0 with a maximum score of 12). A higher score indicates greater drug effect. Used to determine subjective level of drug effect. | At baseline, 20, 30, 60, 90, 120 and 180 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Standard Deviation of Lateral Position (SDLP) - Undistracted | The ability to keep the vehicle straight in the lane and the corresponding data is presented from a rural drive without any secondary tasks relative to the 20 minute baseline drive pre dose. | Over a 20 minute drive conducted at 30, 90 and 180 minutes post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rose A Schmitt, B.S. | Contact | 319-335-4666 | rose-potter@uiowa.edu | |
| Timothy L Brown, Ph.D. | Contact | 319-335-4785 | timothy-l-brown@uiowa.edu |
| Name | Affiliation | Role |
|---|---|---|
| Timothy L Brown, Ph.D. | National Advanced Driving Simulator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Advanced Driving Simulator | Recruiting | Iowa City | Iowa | 52242 | United States |
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| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| D000066448 | Driving Under the Influence |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000066479 | Criminal Behavior |
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| ID | Term |
|---|---|
| D001239 | Inhalation |
| ID | Term |
|---|---|
| D015656 | Respiratory Mechanics |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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| Standard Deviation of Lateral Position (SDLP) - Distracted |
The ability to keep the vehicle straight in the lane and the corresponding data is presented from a rural drive while engaged in a secondary task relative to the 20 minute baseline drive while engaged in the same task pre dose. |
| Over a 20 minute drive conducted at 30, 90 and 180 minutes post dose |
| Blood Delta-9-THC | THC concentration levels of Delta-9-THC in whole blood. | At baseline, 20, 90, and 180 minutes |
| D001519 | Behavior |
| D003617 | Dangerous Behavior |