Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Marijuana and alcohol induced performance changes on Cogstate 1-back/2-back task. |
The Cogstate 1-back/2-back task assesses working memory, it will be administered prior to dosing and at various time points after dosing. |
Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours |
|
| Primary |
Marijuana and alcohol induced performance changes on the Cogstate Social/Emotional Cognition Task. |
The Cogstate Social/Emotional Cognition task assesses emotional processing, it will be administered prior to dosing and at various time points after dosing. |
Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours |
|
| Primary |
Marijuana and alcohol induced performance changes on Cogstate Card Learning. |
The Cogstate Card Learning task assesses visual memory, it will be administered prior to dosing and at various time points after dosing. |
Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours |
|
| Primary |
Marijuana and alcohol induced performance changes on Groton Maze Learning task. |
The Cogstate Groton Maze Learning task assesses spatial learning and memory, it will be administered prior to dosing and at various time points after dosing. |
Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours |
|
| Primary |
Marijuana and alcohol induced performance changes on Alertmeter. |
The Alertmeter task assess visual judgment and alertness, it will be administered prior to dosing and at various time points after dosing. |
Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours |
|
| Primary |
Marijuana and alcohol induced performance changes on the Time Estimation task. |
The Time Estimation Task assesses timing, it will be administered prior to dosing and at various time points after dosing. |
Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours |
|
| Primary |
Marijuana and alcohol induced performance changes on the Go-No-Go task. |
The Go-No-Go task assesses inhibitory processing, it will be administered prior to dosing and at various time points after dosing. |
Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours |
|
| Primary |
Marijuana and alcohol induced performance changes on the Ramaeker's Critical Tracking Test. |
The Raemaker's Critical Tracking Test assesses hand eye coordination and visuomotor tracking, it will be administered prior to dosing and at various time points after dosing. |
Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours |
|
| Primary |
Marijuana and alcohol induced performance changes on the ANAM Pursuit Tracking Task. |
The ANAM Pursuit Tracking Task assesses hand eye coordination, it will be administered prior to dosing and at various time points after dosing. |
Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours |
|
| Primary |
Marijuana and alcohol induced performance changes on the Finger to Nose Task. |
The Finger to Nose Task assesses general motor coordination, it will be administered prior to dosing and at various time points after dosing. |
Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours |
|
| Primary |
Marijuana and alcohol induced performance changes on the One Leg Stand Task. |
The One Leg Stand Task assesses general motor coordination, it will be administered prior to dosing and at various time points after dosing. |
Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours |
|
| Primary |
Marijuana and alcohol induced performance changes on the Line Walking/Months Backwards Task. |
The Line Walking/Months Backwards Task assesses general motor coordination plus distraction, it will be administered prior to dosing and at various time points after dosing. |
Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours |
|
| Primary |
Marijuana and alcohol induced performance changes on the Time Reproduction Task. |
The Time Reproduction Task assesses general motor coordination plus timing, it will be administered prior to dosing and at various time points after dosing. |
Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours |
|
| Primary |
Marijuana and alcohol induced performance changes on the Ipod Balance Task. |
Participants will have an elastic wrap around their hips with an Ipod attached via durable velco. They will be asked to stand with both feet flat on the ground, looking ahead at a fixed point on the wall for 30 seconds, as well as 30 seconds with eyes closed. The amount of body sway will be measured using the accelerometer in an Ipod. |
Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours |
|
| Primary |
Marijuana and alcohol induced performance changes on the Ipod Punching Task. |
Participants will have an elastic wrap around their forearm with an Ipod attached via durable velrco. They will be asking to punch their arm forward while seated in a chair to measure their peak velocity of punching through the accelerometer in the Ipod. |
Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours |
|
| Primary |
Marijuana and alcohol induced performance changes on the DRUID tasks. |
DRUID is an application that has been designed to measure cognitive and behavior impairment following ingestion of drugs such as alcohol or marijuana. DRUID includes four Tasks to measure performance. The tasks are based on research on driving impairment and take about 5 minutes to complete. These tasks include a Reaction Time/Decision Making/DAT in which the subject has to press in two different locations on the Ipod screen dependent on which target shape appeared. The second task is a Reaction Time/Time Estimation/DAT task in which the subjects has to internally count up to 60 seconds while also touching the screen each time a target shape appears on the screen. The third task is a Motor Tracking/DAT tasks in which the subject must keep their finger on a moving circle on the screen. The last task is a balance task in which the subject is told to stand on one foot with the Ipod in an opposite hand keeping it as still as possible. |
Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours |
|
| Secondary |
Change in concentration of THC/metabolites in blood samples. |
Blood samples with be collected at 3 times throughout each day to assess for changes of THC and its metabolite levels. |
Baseline and post drug administration at: 30 min; 2.5 hours |
|
| Secondary |
Change in concentration of THC/metabolites in oral fluid tested using Quantisal Oral Fluid Collection devices. |
Oral fluid samples with be collected at 3 times throughout each day to assess for changes of THC and its metabolite levels. |
Baseline and post drug administration at: 30 min; 2.5 hours |
|
| Secondary |
Change in performance on simulated driving Road Tracking Task. |
The Road Tracking Task measures operational control of the vehicle. Operational control is measured by standard deviation of lane position from the center point of the lane. |
Post drug administration at: 30 min; 2.5 hours, 5 hours |
|
| Secondary |
Change in performance on simulated driving Car Following Task. |
The Car Following Task measures tactical control of the vehicle. Tactical control of the vehicle is measured by following distance from a lead vehicle. |
Post drug administration at: 30 min; 2.5 hours, 5 hours |
|
| Secondary |
Change in performance on simulated driving Gap Acceptance Task. |
The Gap Acceptance Task measures strategic control of the vehicle. Strategic control of the vehicle is measured by size of headway gaps that the participant chooses in pulling out into oncoming traffic to overtake a stopped car. |
Post drug administration at: 30 min; 2.5 hours, 5 hours |
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