Trial Outcomes & Findings for The Impact and Detection of Driving Impairments Associated With Acute Cannabis Smoking (NCT NCT02849587)

NCT ID: NCT02849587

Last Updated: 2022-01-04

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 199 participants
• Primary outcome timeframe: Participants are assessed pre-smoking, and then approximately 30m, 1h 30m, 3h 30m and 4h 30m post-smoking
• Results posted on: 2022-01-04

Participant Flow

Participant milestones

Measure	Placebo Cannabis Participants will smoke placebo cannabis with .02% THC ad libitum	Cannabis With 5.9% THC Participants will smoke cannabis with 5.9% THC ad libitum	Cannabis With 13.4% THC Participants will smoke placebo cannabis with 13.4% THC ad libitum
Overall Study STARTED	65	70	64
Overall Study COMPLETED	63	66	62
Overall Study NOT COMPLETED	2	4	2

Reasons for withdrawal

Measure	Placebo Cannabis Participants will smoke placebo cannabis with .02% THC ad libitum	Cannabis With 5.9% THC Participants will smoke cannabis with 5.9% THC ad libitum	Cannabis With 13.4% THC Participants will smoke placebo cannabis with 13.4% THC ad libitum
Overall Study Oral THC > 5ng/mL prior to treatment (indicating likely recent use)	2	3	2
Overall Study Withdrawal by Subject	0	1	0

Baseline Characteristics

The Impact and Detection of Driving Impairments Associated With Acute Cannabis Smoking

Baseline characteristics by cohort

Measure	Placebo n=63 Participants Cannabis with .02% THC	5.9% THC n=66 Participants Cannabis with 5.9% THC	13.4% THC n=62 Participants Cannabis with 13.4% THC	Total n=191 Participants Total of all reporting groups
Age, Continuous	28.1 years STANDARD_DEVIATION 7.3 • n=5 Participants	30.7 years STANDARD_DEVIATION 8.8 • n=7 Participants	30.9 years STANDARD_DEVIATION 8.6 • n=5 Participants	29.9 years STANDARD_DEVIATION 8.3 • n=4 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	19 Participants n=7 Participants	23 Participants n=5 Participants	73 Participants n=4 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	47 Participants n=7 Participants	39 Participants n=5 Participants	118 Participants n=4 Participants
Race/Ethnicity, Customized African American	8 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	18 Participants n=4 Participants
Race/Ethnicity, Customized Asian	5 Participants n=5 Participants	8 Participants n=7 Participants	4 Participants n=5 Participants	17 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic	15 Participants n=5 Participants	19 Participants n=7 Participants	22 Participants n=5 Participants	56 Participants n=4 Participants
Race/Ethnicity, Customized Indigenous	5 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	8 Participants n=4 Participants
Race/Ethnicity, Customized Multiracial	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Race/Ethnicity, Customized Non-Hispanic White	28 Participants n=5 Participants	28 Participants n=7 Participants	27 Participants n=5 Participants	83 Participants n=4 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment United States	63 participants n=5 Participants	66 participants n=7 Participants	62 participants n=5 Participants	191 participants n=4 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Placebo n=63 Participants Placebo Cannabis	5.9% THC n=66 Participants Cannabis with 5.9% THC	13.4% THC n=62 Participants Cannabis with 13.4% THC
Change in Composite Drive Score (CDS) From Pre-smoking Simulation Pre-smoke	-.09 z-score Standard Deviation .64	.12 z-score Standard Deviation .58	.01 z-score Standard Deviation .52
Change in Composite Drive Score (CDS) From Pre-smoking Simulation 30 minutes	-.17 z-score Standard Deviation .61	.46 z-score Standard Deviation .60	.21 z-score Standard Deviation .60
Change in Composite Drive Score (CDS) From Pre-smoking Simulation 1h 30min	-.13 z-score Standard Deviation .61	.40 z-score Standard Deviation .66	.32 z-score Standard Deviation .59
Change in Composite Drive Score (CDS) From Pre-smoking Simulation 3h 30min	-.23 z-score Standard Deviation .59	.15 z-score Standard Deviation .64	.04 z-score Standard Deviation .57
Change in Composite Drive Score (CDS) From Pre-smoking Simulation 4h 30min	-.07 z-score Standard Deviation .66	.09 z-score Standard Deviation .57	.05 z-score Standard Deviation .59

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Placebo n=63 Participants Placebo Cannabis	5.9% THC n=66 Participants Cannabis with 5.9% THC	13.4% THC n=62 Participants Cannabis with 13.4% THC
Simulator: Standard Deviation of Lateral Position (SDLP) Pre-smoking	1.09 z-score Standard Deviation .36	1.20 z-score Standard Deviation .36	1.11 z-score Standard Deviation 0.35
Simulator: Standard Deviation of Lateral Position (SDLP) 30 min	1.07 z-score Standard Deviation .33	1.24 z-score Standard Deviation .36	1.19 z-score Standard Deviation .36
Simulator: Standard Deviation of Lateral Position (SDLP) 1h 30min	1.06 z-score Standard Deviation .31	1.31 z-score Standard Deviation .39	1.23 z-score Standard Deviation .42
Simulator: Standard Deviation of Lateral Position (SDLP) 3h 30min	1.10 z-score Standard Deviation .31	1.25 z-score Standard Deviation .35	1.20 z-score Standard Deviation .42
Simulator: Standard Deviation of Lateral Position (SDLP) 4h 30min	1.10 z-score Standard Deviation .36	1.25 z-score Standard Deviation .37	1.18 z-score Standard Deviation .42

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Placebo n=63 Participants Placebo Cannabis	5.9% THC n=66 Participants Cannabis with 5.9% THC	13.4% THC n=62 Participants Cannabis with 13.4% THC
Simulator: Speed Deviation Pre-smoking	2.13 miles per hour Standard Deviation 1.81	2.61 miles per hour Standard Deviation 1.97	2.63 miles per hour Standard Deviation 1.98
Simulator: Speed Deviation 30 min	2.03 miles per hour Standard Deviation 1.31	3.04 miles per hour Standard Deviation 1.71	2.99 miles per hour Standard Deviation 2.05
Simulator: Speed Deviation 1h 30min	2.49 miles per hour Standard Deviation 1.70	2.97 miles per hour Standard Deviation 1.93	3.01 miles per hour Standard Deviation 2.03
Simulator: Speed Deviation 3h 30min	2.15 miles per hour Standard Deviation 1.89	3.04 miles per hour Standard Deviation 2.16	2.65 miles per hour Standard Deviation 1.72
Simulator: Speed Deviation 4h 30min	2.34 miles per hour Standard Deviation 1.82	2.92 miles per hour Standard Deviation 2.10	2.34 miles per hour Standard Deviation 1.71

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Placebo n=63 Participants Placebo Cannabis	5.9% THC n=66 Participants Cannabis with 5.9% THC	13.4% THC n=62 Participants Cannabis with 13.4% THC
Simulator: Correct Hits on mSuRT 30 min	30.9 count of correct responses Standard Deviation 1.71	28.7 count of correct responses Standard Deviation 4.23	30.3 count of correct responses Standard Deviation 2.54
Simulator: Correct Hits on mSuRT 1h 30min	30.3 count of correct responses Standard Deviation 2.16	29.6 count of correct responses Standard Deviation 2.56	30.4 count of correct responses Standard Deviation 1.69
Simulator: Correct Hits on mSuRT 3h 30min	30.4 count of correct responses Standard Deviation 2.73	29.7 count of correct responses Standard Deviation 2.61	30.7 count of correct responses Standard Deviation 1.40
Simulator: Correct Hits on mSuRT 4h 30min	31.0 count of correct responses Standard Deviation 1.44	30.3 count of correct responses Standard Deviation 2.65	31.1 count of correct responses Standard Deviation 1.05
Simulator: Correct Hits on mSuRT Pre-smoking	30.7 count of correct responses Standard Deviation 1.80	29.9 count of correct responses Standard Deviation 2.76	30.6 count of correct responses Standard Deviation 1.42

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Placebo n=63 Participants Placebo Cannabis	5.9% THC n=66 Participants Cannabis with 5.9% THC	13.4% THC n=62 Participants Cannabis with 13.4% THC
Simulator: Car Following - Coherence Pre-smoking	.76 Correlation coefficient Standard Deviation .19	.73 Correlation coefficient Standard Deviation .18	.76 Correlation coefficient Standard Deviation .15
Simulator: Car Following - Coherence 30 min	.79 Correlation coefficient Standard Deviation .13	.66 Correlation coefficient Standard Deviation .20	.71 Correlation coefficient Standard Deviation .17
Simulator: Car Following - Coherence 1h 30min	.77 Correlation coefficient Standard Deviation .16	.65 Correlation coefficient Standard Deviation .23	.68 Correlation coefficient Standard Deviation .19
Simulator: Car Following - Coherence 3h 30min	.80 Correlation coefficient Standard Deviation .15	.74 Correlation coefficient Standard Deviation .18	.74 Correlation coefficient Standard Deviation .17
Simulator: Car Following - Coherence 4h 30min	.75 Correlation coefficient Standard Deviation .16	.74 Correlation coefficient Standard Deviation .18	.71 Correlation coefficient Standard Deviation .17

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Placebo n=63 Participants Placebo Cannabis	5.9% THC n=66 Participants Cannabis with 5.9% THC	13.4% THC n=62 Participants Cannabis with 13.4% THC
Simulator: Response Delay - Car Following Pre-smoking	2.92 seconds Standard Deviation 1.15	3.32 seconds Standard Deviation 1.23	3.58 seconds Standard Deviation 1.24
Simulator: Response Delay - Car Following 30 min	2.86 seconds Standard Deviation 1.05	3.44 seconds Standard Deviation 1.15	3.55 seconds Standard Deviation 1.06
Simulator: Response Delay - Car Following 1h 30min	2.80 seconds Standard Deviation .99	3.25 seconds Standard Deviation 1.28	3.49 seconds Standard Deviation 1.04
Simulator: Response Delay - Car Following 3h 30min	2.61 seconds Standard Deviation 1.04	2.83 seconds Standard Deviation 1.05	3.23 seconds Standard Deviation 1.18
Simulator: Response Delay - Car Following 4h 30min	2.93 seconds Standard Deviation 1.05	3.00 seconds Standard Deviation 1.10	3.50 seconds Standard Deviation 1.17

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Placebo n=63 Participants Placebo Cannabis	5.9% THC n=66 Participants Cannabis with 5.9% THC	13.4% THC n=62 Participants Cannabis with 13.4% THC
Simulator: Distance From Lead Car - Car Following Pre-smoking	153 feet Standard Deviation 41	156 feet Standard Deviation 41	163 feet Standard Deviation 35
Simulator: Distance From Lead Car - Car Following 30 min	143 feet Standard Deviation 36	165 feet Standard Deviation 39	164 feet Standard Deviation 39
Simulator: Distance From Lead Car - Car Following 1h 30min	144 feet Standard Deviation 34	160 feet Standard Deviation 38	165 feet Standard Deviation 36
Simulator: Distance From Lead Car - Car Following 3h 30min	129 feet Standard Deviation 33	137 feet Standard Deviation 37	150 feet Standard Deviation 34
Simulator: Distance From Lead Car - Car Following 4h 30min	138 feet Standard Deviation 34	136 feet Standard Deviation 37	151 feet Standard Deviation 36

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Placebo n=63 Participants Placebo Cannabis	5.9% THC n=66 Participants Cannabis with 5.9% THC	13.4% THC n=62 Participants Cannabis with 13.4% THC
Tablet Assessment: Dual Attention Missed Switches Pre-smoking	0.095 Proportion of participants Interval 0.039 to 0.202	0.145 Proportion of participants Interval 0.073 to 0.263	0.167 Proportion of participants Interval 0.087 to 0.29
Tablet Assessment: Dual Attention Missed Switches 1 hour	0.095 Proportion of participants Interval 0.039 to 0.202	0.194 Proportion of participants Interval 0.108 to 0.317	0.183 Proportion of participants Interval 0.099 to 0.309
Tablet Assessment: Dual Attention Missed Switches 2 hours	0.175 Proportion of participants Interval 0.095 to 0.295	0.161 Proportion of participants Interval 0.084 to 0.281	0.233 Proportion of participants Interval 0.138 to 0.363
Tablet Assessment: Dual Attention Missed Switches 4 hours	0.191 Proportion of participants Interval 0.106 to 0.313	0.177 Proportion of participants Interval 0.096 to 0.299	0.167 Proportion of participants Interval 0.087 to 0.29
Tablet Assessment: Dual Attention Missed Switches 5 hours	0.095 Proportion of participants Interval 0.039 to 0.202	0.129 Proportion of participants Interval 0.061 to 0.244	0.183 Proportion of participants Interval 0.099 to 0.309

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Placebo n=63 Participants Placebo Cannabis	5.9% THC n=66 Participants Cannabis with 5.9% THC	13.4% THC n=62 Participants Cannabis with 13.4% THC
Tablet Assessment: Lane Tracking Standard Deviation Pre-smoking	26.9 standard deviation of position Standard Deviation 9.53	30.9 standard deviation of position Standard Deviation 23.7	27.2 standard deviation of position Standard Deviation 9.67
Tablet Assessment: Lane Tracking Standard Deviation 1 hour	28.7 standard deviation of position Standard Deviation 13.4	30.9 standard deviation of position Standard Deviation 15.7	32.1 standard deviation of position Standard Deviation 21.7
Tablet Assessment: Lane Tracking Standard Deviation 2 hours	28.4 standard deviation of position Standard Deviation 10.3	27.6 standard deviation of position Standard Deviation 10.2	27.4 standard deviation of position Standard Deviation 10.4
Tablet Assessment: Lane Tracking Standard Deviation 4 hours	28.1 standard deviation of position Standard Deviation 13.3	29.9 standard deviation of position Standard Deviation 15.5	28.6 standard deviation of position Standard Deviation 14.8
Tablet Assessment: Lane Tracking Standard Deviation 5 hours	26.4 standard deviation of position Standard Deviation 10.8	25.4 standard deviation of position Standard Deviation 8.39	25.3 standard deviation of position Standard Deviation 13.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Placebo n=63 Participants Placebo Cannabis	5.9% THC n=66 Participants Cannabis with 5.9% THC	13.4% THC n=62 Participants Cannabis with 13.4% THC
Tablet Assessment: Visual Spatial Learning Test Number Correct Pre-smoking	9.9 number of correct responses Standard Deviation 2.3	9.7 number of correct responses Standard Deviation 2.7	10.1 number of correct responses Standard Deviation 2.2
Tablet Assessment: Visual Spatial Learning Test Number Correct 1 hour	9.1 number of correct responses Standard Deviation 2.8	8.4 number of correct responses Standard Deviation 2.6	9.3 number of correct responses Standard Deviation 2.7
Tablet Assessment: Visual Spatial Learning Test Number Correct 2 hours	8.9 number of correct responses Standard Deviation 3.1	8.7 number of correct responses Standard Deviation 2.6	8.9 number of correct responses Standard Deviation 2.7
Tablet Assessment: Visual Spatial Learning Test Number Correct 4 hours	8.5 number of correct responses Standard Deviation 3.0	8.3 number of correct responses Standard Deviation 2.9	8.8 number of correct responses Standard Deviation 2.5
Tablet Assessment: Visual Spatial Learning Test Number Correct 5 hours	9.3 number of correct responses Standard Deviation 2.9	8.5 number of correct responses Standard Deviation 3.0	9.5 number of correct responses Standard Deviation 3.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Placebo n=63 Participants Placebo Cannabis	5.9% THC n=66 Participants Cannabis with 5.9% THC	13.4% THC n=62 Participants Cannabis with 13.4% THC
Tablet Assessment: Time Estimation 1 hour	0.79 Ratio of estimated/actual time Standard Deviation 0.21	0.89 Ratio of estimated/actual time Standard Deviation 0.30	0.85 Ratio of estimated/actual time Standard Deviation 0.24
Tablet Assessment: Time Estimation 2 hours	0.83 Ratio of estimated/actual time Standard Deviation 0.20	0.96 Ratio of estimated/actual time Standard Deviation 0.30	0.87 Ratio of estimated/actual time Standard Deviation 0.27
Tablet Assessment: Time Estimation 4 hours	0.85 Ratio of estimated/actual time Standard Deviation 0.23	0.93 Ratio of estimated/actual time Standard Deviation 0.23	0.86 Ratio of estimated/actual time Standard Deviation 0.21
Tablet Assessment: Time Estimation 5 hours	0.83 Ratio of estimated/actual time Standard Deviation 0.20	0.89 Ratio of estimated/actual time Standard Deviation 0.28	0.85 Ratio of estimated/actual time Standard Deviation 0.21
Tablet Assessment: Time Estimation Pre-smoking	0.75 Ratio of estimated/actual time Standard Deviation 0.19	0.83 Ratio of estimated/actual time Standard Deviation 0.30	0.77 Ratio of estimated/actual time Standard Deviation 0.22

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Placebo n=63 Participants Placebo Cannabis	5.9% THC n=66 Participants Cannabis with 5.9% THC	13.4% THC n=62 Participants Cannabis with 13.4% THC
Tablet Assessment: Balance Pre-smoking	0.358 meters Standard Deviation 0.058	0.360 meters Standard Deviation 0.067	0.356 meters Standard Deviation 0.058
Tablet Assessment: Balance 1 hour	0.342 meters Standard Deviation 0.054	0.376 meters Standard Deviation 0.090	0.363 meters Standard Deviation 0.129
Tablet Assessment: Balance 2 hours	0.351 meters Standard Deviation 0.053	0.394 meters Standard Deviation 0.161	0.414 meters Standard Deviation 0.254
Tablet Assessment: Balance 4 hours	0.354 meters Standard Deviation 0.058	0.386 meters Standard Deviation 0.131	0.377 meters Standard Deviation 0.133
Tablet Assessment: Balance 5 hours	0.368 meters Standard Deviation 0.059	0.371 meters Standard Deviation 0.054	0.365 meters Standard Deviation 0.072

SECONDARY outcome

Timeframe: Approximately 15 minutes post-smoking

Spearman's correlation between THC concentrations in whole blood and oral fluid. Higher scores are better.

Outcome measures

Measure	Placebo n=63 Participants Placebo Cannabis	5.9% THC n=66 Participants Cannabis with 5.9% THC	13.4% THC n=62 Participants Cannabis with 13.4% THC
THC Concentrations: Correlation Between Blood and Oral Fluid	0.217 Spearman's rho Interval -0.034 to 0.443	0.414 Spearman's rho Interval 0.19 to 0.598	0.249 Spearman's rho Interval -0.003 to 0.471

SECONDARY outcome

Timeframe: Approximately 15 minutes post-smoking

Spearman's correlation between THC concentrations in whole blood and breath

Outcome measures

Measure	Placebo n=63 Participants Placebo Cannabis	5.9% THC n=66 Participants Cannabis with 5.9% THC	13.4% THC n=62 Participants Cannabis with 13.4% THC
THC Concentrations: Correlation Between Whole Blood and Breath	0.134 Spearman's rho Interval -0.12 to 0.371	-0.258 Spearman's rho Interval -0.472 to -0.015	-0.176 Spearman's rho Interval -0.41 to 0.079

Adverse Events

Placebo Cannabis

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Cannabis With 5.9% THC

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Cannabis With 13.4% THC

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo Cannabis n=65 participants at risk Placebo Cannabis (.02% THC)	Cannabis With 5.9% THC n=70 participants at risk Cannabis with 5.9% THC, smoked ad libitum	Cannabis With 13.4% THC n=64 participants at risk Cannabis with 13.4% THC, smoked ad libitum
Psychiatric disorders Anxiety	0.00% 0/65 • One day (acute administration)	2.9% 2/70 • Number of events 2 • One day (acute administration)	0.00% 0/64 • One day (acute administration)
Nervous system disorders Dizziness	0.00% 0/65 • One day (acute administration)	4.3% 3/70 • Number of events 3 • One day (acute administration)	4.7% 3/64 • Number of events 3 • One day (acute administration)
Gastrointestinal disorders Nausea	0.00% 0/65 • One day (acute administration)	2.9% 2/70 • Number of events 2 • One day (acute administration)	1.6% 1/64 • Number of events 1 • One day (acute administration)
Nervous system disorders Sweats	0.00% 0/65 • One day (acute administration)	2.9% 2/70 • Number of events 2 • One day (acute administration)	0.00% 0/64 • One day (acute administration)
Vascular disorders Blood Pressure Decreased	0.00% 0/65 • One day (acute administration)	4.3% 3/70 • Number of events 3 • One day (acute administration)	1.6% 1/64 • Number of events 1 • One day (acute administration)
Vascular disorders Blood Pressure Increased	0.00% 0/65 • One day (acute administration)	2.9% 2/70 • Number of events 2 • One day (acute administration)	0.00% 0/64 • One day (acute administration)
Cardiac disorders Heart Rate Abnormal	0.00% 0/65 • One day (acute administration)	17.1% 12/70 • Number of events 12 • One day (acute administration)	1.6% 1/64 • Number of events 1 • One day (acute administration)
General disorders Cervicalgia	0.00% 0/65 • One day (acute administration)	1.4% 1/70 • Number of events 1 • One day (acute administration)	0.00% 0/64 • One day (acute administration)
Vascular disorders Fainting	0.00% 0/65 • One day (acute administration)	1.4% 1/70 • Number of events 1 • One day (acute administration)	0.00% 0/64 • One day (acute administration)
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/65 • One day (acute administration)	0.00% 0/70 • One day (acute administration)	1.6% 1/64 • Number of events 1 • One day (acute administration)
Injury, poisoning and procedural complications Discomfort in arm	1.5% 1/65 • Number of events 1 • One day (acute administration)	1.4% 1/70 • Number of events 1 • One day (acute administration)	0.00% 0/64 • One day (acute administration)
Injury, poisoning and procedural complications Swollen arm	0.00% 0/65 • One day (acute administration)	0.00% 0/70 • One day (acute administration)	1.6% 1/64 • Number of events 1 • One day (acute administration)
Injury, poisoning and procedural complications Numbness in arm	1.5% 1/65 • Number of events 1 • One day (acute administration)	0.00% 0/70 • One day (acute administration)	0.00% 0/64 • One day (acute administration)
General disorders Fever	0.00% 0/65 • One day (acute administration)	1.4% 1/70 • Number of events 1 • One day (acute administration)	0.00% 0/64 • One day (acute administration)

Additional Information

Thomas D. Marcotte, Phd

University of California, San Diego; Center for Medicinal Cannabis Research

Phone: 619-543-5044

Email: tmarcotte@ucsd.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place