Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 14 of 14

List	Outcome	Time frame	Description
Primary	Change in Composite Drive Score (CDS) From Pre-smoking Simulation	Participants are assessed pre-smoking, and then approximately 30m, 1h 30m, 3h 30m and 4h 30m post-smoking	The Composite Drive Score (CDS) is a z-score comprised of key variables from the simulator tasks (SDLP, speed deviation, and task accuracy during the modified Surrogate Reference Task (mSuRT); coherence from the car following task). This outcome reflects the change in CDS from the pre-smoking assessment, at each timepoint. The z-score indicates the number of standard deviations away from the mean from the baseline performance for the entire group (n = 191). A Z-score of 0 is equal to the mean of a reference population (in this case the pre-smoking performance for the entire group). Higher z-scores at each timepoint indicate worse performance (variables that went in the opposite direction were reflected in order to have all variables have the same direction). When examining the change in Composite Drive Score (this outcome variable), a higher score indicates a decline in performance (e.g., Time 2 minus Time 1).
Secondary	Simulator: Standard Deviation of Lateral Position (SDLP)	Participants are assessed pre-smoking, and then approximately 30m, 1h 30m, 3h 30m and 4h 30m post-smoking	This measures the standard deviation of lateral (lane) position, or the degree to which the participant "swerves" within the road lane on the driving simulation during the modified Surrogate Reference Task (mSuRT). The range is from .39 to 3.33. A higher score indicates worse performance.
Secondary	Simulator: Speed Deviation	Participants are assessed pre-smoking, and then approximately 30m, 1h 30m, 3h 30m and 4h 30m post-smoking	The variability in speed during the modified Surrogate Reference Test (mSuRT). The speed is in miles per hour. Range is from .17 to 12.85. A higher score indicates worse performance.
Secondary	Simulator: Correct Hits on mSuRT	Participants are assessed pre-smoking, and then approximately 30m, 1h 30m, 3h 30m and 4h 30m post-smoking	The number of times the participant touched the correct stimulus (circle) on the iPad, during modified Surrogate Reference Task (mSuRT). Range is from 8 to 32. A higher score is a better score.
Secondary	Simulator: Car Following - Coherence	Participants are assessed pre-smoking, and then approximately 30m, 1h 30m, 3h 30m and 4h 30m post-smoking	Coherence is the correlation (0 to 1) between the participant and the lead car (which speeds up and slows down), representing the participant's ability to accurately speed up and slow down similarly to the lead car. Range of scores is from .01 to .97. A higher score is a better score.
Secondary	Simulator: Response Delay - Car Following	Participants are assessed pre-smoking, and then approximately 30m, 1h 30m, 3h 30m and 4h 30m post-smoking	Time delay (in seconds) in responding to changes in the lead car's speed. Range is from -5.8 to 6.0. A higher score indicates a worse score.
Secondary	Simulator: Distance From Lead Car - Car Following	Participants are assessed pre-smoking, and then approximately 30m, 1h 30m, 3h 30m and 4h 30m post-smoking	The outcome is distance from the lead car (in virtual feet) during the Car Following Task
Secondary	Tablet Assessment: Dual Attention Missed Switches	Participants assessed pre-smoking and 1 hour, 2 hours, 4 hours, and 5 hours after smoking	The participant follows a moving target (square) with her/his finger, and switches to following a new stimulus when it appears in the corner of the screen. Each participant was classified as to whether he/she missed any of these switches during the trial. The outcome is the proportion of participants within each group who missed at least one switch. The range is from 0 to 1. Higher indicates a worse score.
Secondary	Tablet Assessment: Lane Tracking Standard Deviation	Participants assessed pre-smoking and 1 hour, 2 hours, 4 hours, and 5 hours after smoking	The participant is to rotate the iPad in order to keep a round object in the center, between two lines (lanes). This measure is the standard deviation of the position of the round object during the task (in essence, how much "swerving" there is within the lane). The range is from 8.2 to 189.4. A higher score indicates worse performance.
Secondary	Tablet Assessment: Visual Spatial Learning Test Number Correct	Participants assessed pre-smoking and 1 hour, 2 hours, 4 hours, and 5 hours after smoking	Assessment of short-term memory for abstract figures. The participant is to memorize abstract figures and their locations on a 3 x 3 grid. After initial viewing (10 seconds), the figures go away for either 4, 12, or 24 seconds. The participant is then to identify which figures were in the initial viewing (from a list at the bottom of the screen), and place them at the correct location. This is the number of correctly identified figures. The range is from 0 to 12. A higher score indicates better performance.
Secondary	Tablet Assessment: Time Estimation	Participants assessed pre-smoking and 1 hour, 2 hours, 4 hours, and 5 hours after smoking	The participant is to estimate the amount of time that has passed while performing a secondary task. This outcome is the ratio of 1) the estimated time that has passed (seconds), divided by 2) the actual amount of time that has passed. The range is from 0.204 to 1.89. A higher score indicates a better performance.
Secondary	Tablet Assessment: Balance	Participants assessed pre-smoking and 1 hour, 2 hours, 4 hours, and 5 hours after smoking	While standing and keeping their feet still, this is a measure of the participant's "sway", which is the total distance that the participant's body moved (in meters) from his/her initial vertical position. This was measured using an accelerometer placed on the participant's back. The range of scores is from .222 to 1.661. A higher score indicates worse performance.
Secondary	THC Concentrations: Correlation Between Blood and Oral Fluid	Approximately 15 minutes post-smoking	Spearman's correlation between THC concentrations in whole blood and oral fluid. Higher scores are better.
Secondary	THC Concentrations: Correlation Between Whole Blood and Breath	Approximately 15 minutes post-smoking	Spearman's correlation between THC concentrations in whole blood and breath

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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