The Impact and Detection of Driving Impairments Associated With Acute Cannabis Smoking
Study Details
Study Description
Brief Summary
This study was authorized by the California Legislature (Assembly Bill 266, the Medical Marijuana Regulation and Safety Act to help with detection of driving under the influence of cannabis. One hundred and eighty healthy volunteers will inhale smoked cannabis with either 0% (placebo), 5.9%, or 13.4% Δ9-tetrahydrocannabinol (THC) at the beginning of the day, and then complete driving simulations, iPad-based performance assessments, and bodily fluid draws (e.g., blood, saliva, breath) before the cannabis smoking and a number of times over the subsequent 6 hours after cannabis smoking. The purpose is to determine (1) the relationship of the dose of Δ9-THC on driving performance and (2) the duration of driving impairment in terms of hours from initial use, (3) if saliva or expired air can serve as a useful substitute for blood sampling of Δ9-THC, and (4) if testing using an iPad can serve as a useful adjunct to the standardized field sobriety test in identifying acute impairment from cannabis.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1/Phase 2 |
Detailed Description
There are several studies that suggest higher doses of whole-blood Δ9-tetrahydrocannabinol (Δ9-THC) concentration are associated with increased crash risk and crash culpability. However, attempts to define a cut-off point for blood Δ9-THC levels have proven to be challenging. Unlike alcohol, for which a level can be reasonably measured using a breathalyzer (and confirmed with a blood test), detection of a cut-off point for intoxication related to Δ9-THC concentration has eluded scientific verification. Recent evidence suggests blood Δ9-THC concentrations of 2-5 ng/mL are associated with substantial driving impairment, particularly in occasional smokers. Others have countered that this level leads to false positives, particularly in heavy cannabis users inasmuch as THC may be detectable in their blood specimens for 12-24 hours after inhalation. Given that 12 to 24 hours is beyond the likely period of driving impairment, this would appear to be a justifiable objection to a per se cut-off point for a Δ9-THC concentration indicative of impairment. Maximal driving impairment is found 20 to 40 minutes after smoking, and the risk of driving impairment decreases over the following hours, at least in those who smoke 18 mg Δ9-THC or less, the dose often used experimentally to duplicate a single joint. Other studies, however, report residual motor vehicle accident crash risk when cannabis is used within 4 hours prior to driving.
The roadside examination using the Standardized Field Sobriety Test (SFST) for proof of cannabis-related impairment has not been an ideal alternative to blood levels. Originally devised to evaluate impairment under the influence of alcohol, the SFST is comprised of three examinations administered in a standardized manner by law enforcement officers. The 'Horizontal Gaze Nystagmus' (HGN), the 'One Leg Stand' (OLS) and the 'Walk and Turn' test (WAT) require a person to follow instructions and perform motor activities. During the assessments, officers observe and record signs of impairment. In one study, Δ9-THC produced impairments on overall SFST performance in 50 % of the participants. In a separate study involving acute administration of cannabis, 30% of people failed the SFST. This discrepancy was thought to be in part due to the participant's cannabis use history, as well as low percentage of THC in the cannabis. The reported frequency of cannabis use varied from once a week to once every 2-6 months in the study where there was a failure on the SFST by 50% of the participants. The other study included more frequent users who smoked cannabis on at least four occasions per week.
Based upon the above, another means is needed to help law enforcement officers discern driving under the influence of cannabis. One future possibility is the development of performance-based measures of cannabis-related impairments. This will include testing of critical tracking, time estimation, balance and visual spatial learning. The investigators have selected brief measures in order to be practicably administered repeatedly over a short time period, as well as tests that have the potential to translate to a field-feasible tablet-based format, should there be benefit in possibly including these in future performance-based measures for use in the field by law enforcement officers (e.g., a cannabis-focused field sobriety test).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Placebo Comparator: Placebo Cannabis Subjects will smoke cannabis with placebo THC (.02%) ad libitum |
Drug: Cannabis
Participants will smoke a cannabis cigarette ad libitum as per their usual routine
Other Names:
|
Experimental: Cannabis with 5.9% THC Subjects will smoke cannabis cigarettes with 5.9% THC ad libitum |
Drug: Cannabis
Participants will smoke a cannabis cigarette ad libitum as per their usual routine
Other Names:
|
Experimental: Cannabis with 13.4% THC Subjects will smoke cannabis cigarettes with 13.4% THC ad libitum |
Drug: Cannabis
Participants will smoke a cannabis cigarette ad libitum as per their usual routine
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- THC Concentrations: Correlation Between Whole Blood and Breath [Approximately 15 minutes post-smoking]
Spearman's correlation between THC concentrations in whole blood and breath
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Be a licensed driver.
-
Need to have acuity of 20/40 or better, with or without correction on a Snellen Visual Acuity eye chart.
Exclusion Criteria:
-
At the discretion of the examining physician, individuals with significant cardiovascular, hepatic or renal disease, uncontrolled hypertension, and chronic pulmonary disease (eg, asthma, COPD) will be excluded.
-
Unwillingness to abstain from cannabis for 2 days prior to screening and experimental visits
-
Positive pregnancy test
-
A positive result on toxicity screening for cocaine, amphetamines, opiates, and phencyclidine (PCP) will exclude individuals from participation.
-
Unwilling to refrain from driving or operating heavy machinery for four hours after consuming study medication.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Center for Medicinal Cannabis Research, UC San Diego | San Diego | California | United States | 92103 |
Sponsors and Collaborators
- University of California, San Diego
Investigators
- Principal Investigator: Thomas D Marcotte, PhD, University of California, San Diego
Study Documents (Full-Text)
More Information
Additional Information:
Publications
- Beck O, Stephanson N, Sandqvist S, Franck J. Detection of drugs of abuse in exhaled breath from users following recovery from intoxication. J Anal Toxicol. 2012 Nov-Dec;36(9):638-46. doi: 10.1093/jat/bks079. Epub 2012 Oct 7.
- Fabritius M, Chtioui H, Battistella G, Annoni JM, Dao K, Favrat B, Fornari E, Lauer E, Maeder P, Giroud C. Comparison of cannabinoid concentrations in oral fluid and whole blood between occasional and regular cannabis smokers prior to and after smoking a cannabis joint. Anal Bioanal Chem. 2013 Dec;405(30):9791-803. doi: 10.1007/s00216-013-7412-1. Epub 2013 Nov 8.
- Hartman RL, Huestis MA. Cannabis effects on driving skills. Clin Chem. 2013 Mar;59(3):478-92. doi: 10.1373/clinchem.2012.194381. Epub 2012 Dec 7. Review.
- Marcotte TD, Heaton RK, Wolfson T, Taylor MJ, Alhassoon O, Arfaa K, Ellis RJ, Grant I. The impact of HIV-related neuropsychological dysfunction on driving behavior. The HNRC Group. J Int Neuropsychol Soc. 1999 Nov;5(7):579-92. Erratum in: J Int Neuropsychol Soc 2000 Nov;6(7):854.
- Marcotte TD, Rosenthal TJ, Roberts E, Lampinen S, Scott JC, Allen RW, Corey-Bloom J. The contribution of cognition and spasticity to driving performance in multiple sclerosis. Arch Phys Med Rehabil. 2008 Sep;89(9):1753-8. doi: 10.1016/j.apmr.2007.12.049.
- Papafotiou K, Carter JD, Stough C. An evaluation of the sensitivity of the Standardised Field Sobriety Tests (SFSTs) to detect impairment due to marijuana intoxication. Psychopharmacology (Berl). 2005 Jun;180(1):107-14. Epub 2004 Dec 24.
- 160641
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Placebo Cannabis | Cannabis With 5.9% THC | Cannabis With 13.4% THC |
---|---|---|---|
Arm/Group Description | Participants will smoke placebo cannabis with .02% THC ad libitum | Participants will smoke cannabis with 5.9% THC ad libitum | Participants will smoke placebo cannabis with 13.4% THC ad libitum |
Period Title: Overall Study | |||
STARTED | 65 | 70 | 64 |
COMPLETED | 63 | 66 | 62 |
NOT COMPLETED | 2 | 4 | 2 |
Baseline Characteristics
Arm/Group Title | Placebo | 5.9% THC | 13.4% THC | Total |
---|---|---|---|---|
Arm/Group Description | Cannabis with .02% THC | Cannabis with 5.9% THC | Cannabis with 13.4% THC | Total of all reporting groups |
Overall Participants | 63 | 66 | 62 | 191 |
Age (years) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [years] |
28.1
(7.3)
|
30.7
(8.8)
|
30.9
(8.6)
|
29.9
(8.3)
|
Sex: Female, Male (Count of Participants) | ||||
Female |
31
49.2%
|
19
28.8%
|
23
37.1%
|
73
38.2%
|
Male |
32
50.8%
|
47
71.2%
|
39
62.9%
|
118
61.8%
|
Race/Ethnicity, Customized (Count of Participants) | ||||
African American |
8
12.7%
|
6
9.1%
|
4
6.5%
|
18
9.4%
|
Asian |
5
7.9%
|
8
12.1%
|
4
6.5%
|
17
8.9%
|
Hispanic |
15
23.8%
|
19
28.8%
|
22
35.5%
|
56
29.3%
|
Indigenous |
5
7.9%
|
2
3%
|
1
1.6%
|
8
4.2%
|
Multiracial |
2
3.2%
|
3
4.5%
|
2
3.2%
|
7
3.7%
|
Non-Hispanic White |
28
44.4%
|
28
42.4%
|
27
43.5%
|
83
43.5%
|
Unknown |
0
0%
|
0
0%
|
2
3.2%
|
2
1%
|
Region of Enrollment (participants) [Number] | ||||
United States |
63
100%
|
66
100%
|
62
100%
|
191
100%
|
Outcome Measures
Title | Change in Composite Drive Score (CDS) From Pre-smoking Simulation |
---|---|
Description | 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). |
Time Frame | Participants are assessed pre-smoking, and then approximately 30m, 1h 30m, 3h 30m and 4h 30m post-smoking |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Placebo | 5.9% THC | 13.4% THC |
---|---|---|---|
Arm/Group Description | Placebo Cannabis | Cannabis with 5.9% THC | Cannabis with 13.4% THC |
Measure Participants | 63 | 66 | 62 |
Pre-smoke |
-.09
(.64)
|
.12
(.58)
|
.01
(.52)
|
30 minutes |
-.17
(.61)
|
.46
(.60)
|
.21
(.60)
|
1h 30min |
-.13
(.61)
|
.40
(.66)
|
.32
(.59)
|
3h 30min |
-.23
(.59)
|
.15
(.64)
|
.04
(.57)
|
4h 30min |
-.07
(.66)
|
.09
(.57)
|
.05
(.59)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, 5.9% THC, 13.4% THC |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | ||
Method | Generalized least squares model | |
Comments |
Title | Simulator: Standard Deviation of Lateral Position (SDLP) |
---|---|
Description | 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. |
Time Frame | Participants are assessed pre-smoking, and then approximately 30m, 1h 30m, 3h 30m and 4h 30m post-smoking |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Placebo | 5.9% THC | 13.4% THC |
---|---|---|---|
Arm/Group Description | Placebo Cannabis | Cannabis with 5.9% THC | Cannabis with 13.4% THC |
Measure Participants | 63 | 66 | 62 |
Pre-smoking |
1.09
(.36)
|
1.20
(.36)
|
1.11
(0.35)
|
30 min |
1.07
(.33)
|
1.24
(.36)
|
1.19
(.36)
|
1h 30min |
1.06
(.31)
|
1.31
(.39)
|
1.23
(.42)
|
3h 30min |
1.10
(.31)
|
1.25
(.35)
|
1.20
(.42)
|
4h 30min |
1.10
(.36)
|
1.25
(.37)
|
1.18
(.42)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, 5.9% THC, 13.4% THC |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.022 |
Comments | ||
Method | Generalized least squares model | |
Comments | Raw data converted to z-score based on pre-smoking performance of entire sample. |
Title | Simulator: Speed Deviation |
---|---|
Description | 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. |
Time Frame | Participants are assessed pre-smoking, and then approximately 30m, 1h 30m, 3h 30m and 4h 30m post-smoking |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Placebo | 5.9% THC | 13.4% THC |
---|---|---|---|
Arm/Group Description | Placebo Cannabis | Cannabis with 5.9% THC | Cannabis with 13.4% THC |
Measure Participants | 63 | 66 | 62 |
Pre-smoking |
2.13
(1.81)
|
2.61
(1.97)
|
2.63
(1.98)
|
30 min |
2.03
(1.31)
|
3.04
(1.71)
|
2.99
(2.05)
|
1h 30min |
2.49
(1.70)
|
2.97
(1.93)
|
3.01
(2.03)
|
3h 30min |
2.15
(1.89)
|
3.04
(2.16)
|
2.65
(1.72)
|
4h 30min |
2.34
(1.82)
|
2.92
(2.10)
|
2.34
(1.71)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, 5.9% THC, 13.4% THC |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.283 |
Comments | ||
Method | Generalized least squares model | |
Comments |
Title | Simulator: Correct Hits on mSuRT |
---|---|
Description | 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. |
Time Frame | Participants are assessed pre-smoking, and then approximately 30m, 1h 30m, 3h 30m and 4h 30m post-smoking |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Placebo | 5.9% THC | 13.4% THC |
---|---|---|---|
Arm/Group Description | Placebo Cannabis | Cannabis with 5.9% THC | Cannabis with 13.4% THC |
Measure Participants | 63 | 66 | 62 |
Pre-smoking |
30.7
(1.80)
|
29.9
(2.76)
|
30.6
(1.42)
|
30 min |
30.9
(1.71)
|
28.7
(4.23)
|
30.3
(2.54)
|
1h 30min |
30.3
(2.16)
|
29.6
(2.56)
|
30.4
(1.69)
|
3h 30min |
30.4
(2.73)
|
29.7
(2.61)
|
30.7
(1.40)
|
4h 30min |
31.0
(1.44)
|
30.3
(2.65)
|
31.1
(1.05)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, 5.9% THC, 13.4% THC |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.0503 |
Comments | ||
Method | Generalized estimating equations model | |
Comments |
Title | Simulator: Car Following - Coherence |
---|---|
Description | 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. |
Time Frame | Participants are assessed pre-smoking, and then approximately 30m, 1h 30m, 3h 30m and 4h 30m post-smoking |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Placebo | 5.9% THC | 13.4% THC |
---|---|---|---|
Arm/Group Description | Placebo Cannabis | Cannabis with 5.9% THC | Cannabis with 13.4% THC |
Measure Participants | 63 | 66 | 62 |
Pre-smoking |
.76
(.19)
|
.73
(.18)
|
.76
(.15)
|
30 min |
.79
(.13)
|
.66
(.20)
|
.71
(.17)
|
1h 30min |
.77
(.16)
|
.65
(.23)
|
.68
(.19)
|
3h 30min |
.80
(.15)
|
.74
(.18)
|
.74
(.17)
|
4h 30min |
.75
(.16)
|
.74
(.18)
|
.71
(.17)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, 5.9% THC, 13.4% THC |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.024 |
Comments | ||
Method | Generalized least squares model | |
Comments |
Title | Simulator: Response Delay - Car Following |
---|---|
Description | 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. |
Time Frame | Participants are assessed pre-smoking, and then approximately 30m, 1h 30m, 3h 30m and 4h 30m post-smoking |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Placebo | 5.9% THC | 13.4% THC |
---|---|---|---|
Arm/Group Description | Placebo Cannabis | Cannabis with 5.9% THC | Cannabis with 13.4% THC |
Measure Participants | 63 | 66 | 62 |
Pre-smoking |
2.92
(1.15)
|
3.32
(1.23)
|
3.58
(1.24)
|
30 min |
2.86
(1.05)
|
3.44
(1.15)
|
3.55
(1.06)
|
1h 30min |
2.80
(.99)
|
3.25
(1.28)
|
3.49
(1.04)
|
3h 30min |
2.61
(1.04)
|
2.83
(1.05)
|
3.23
(1.18)
|
4h 30min |
2.93
(1.05)
|
3.00
(1.10)
|
3.50
(1.17)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, 5.9% THC, 13.4% THC |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.716 |
Comments | ||
Method | Generalized least squares model | |
Comments | The outcome was standardized prior to analyses. |
Title | Simulator: Distance From Lead Car - Car Following |
---|---|
Description | The outcome is distance from the lead car (in virtual feet) during the Car Following Task |
Time Frame | Participants are assessed pre-smoking, and then approximately 30m, 1h 30m, 3h 30m and 4h 30m post-smoking |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Placebo | 5.9% THC | 13.4% THC |
---|---|---|---|
Arm/Group Description | Placebo Cannabis | Cannabis with 5.9% THC | Cannabis with 13.4% THC |
Measure Participants | 63 | 66 | 62 |
Pre-smoking |
153
(41)
|
156
(41)
|
163
(35)
|
30 min |
143
(36)
|
165
(39)
|
164
(39)
|
1h 30min |
144
(34)
|
160
(38)
|
165
(36)
|
3h 30min |
129
(33)
|
137
(37)
|
150
(34)
|
4h 30min |
138
(34)
|
136
(37)
|
151
(36)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, 5.9% THC, 13.4% THC |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.005 |
Comments | ||
Method | Generalized least squares model | |
Comments | The outcome was standardized prior to analysis. |
Title | Tablet Assessment: Dual Attention Missed Switches |
---|---|
Description | 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. |
Time Frame | Participants assessed pre-smoking and 1 hour, 2 hours, 4 hours, and 5 hours after smoking |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Placebo | 5.9% THC | 13.4% THC |
---|---|---|---|
Arm/Group Description | Placebo Cannabis | Cannabis with 5.9% THC | Cannabis with 13.4% THC |
Measure Participants | 63 | 66 | 62 |
Pre-smoking |
0.095
0.2%
|
0.145
0.2%
|
0.167
0.3%
|
1 hour |
0.095
0.2%
|
0.194
0.3%
|
0.183
0.3%
|
2 hours |
0.175
0.3%
|
0.161
0.2%
|
0.233
0.4%
|
4 hours |
0.191
0.3%
|
0.177
0.3%
|
0.167
0.3%
|
5 hours |
0.095
0.2%
|
0.129
0.2%
|
0.183
0.3%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, 5.9% THC, 13.4% THC |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | .366 |
Comments | ||
Method | Generalized Estimating Equations model | |
Comments |
Title | Tablet Assessment: Lane Tracking Standard Deviation |
---|---|
Description | 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. |
Time Frame | Participants assessed pre-smoking and 1 hour, 2 hours, 4 hours, and 5 hours after smoking |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Placebo | 5.9% THC | 13.4% THC |
---|---|---|---|
Arm/Group Description | Placebo Cannabis | Cannabis with 13.4% THC | Cannabis with 13.4% THC |
Measure Participants | 63 | 66 | 62 |
Pre-smoking |
26.9
(9.53)
|
30.9
(23.7)
|
27.2
(9.67)
|
1 hour |
28.7
(13.4)
|
30.9
(15.7)
|
32.1
(21.7)
|
2 hours |
28.4
(10.3)
|
27.6
(10.2)
|
27.4
(10.4)
|
4 hours |
28.1
(13.3)
|
29.9
(15.5)
|
28.6
(14.8)
|
5 hours |
26.4
(10.8)
|
25.4
(8.39)
|
25.3
(13.8)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, 5.9% THC, 13.4% THC |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | .225 |
Comments | ||
Method | Generalized least squares model | |
Comments | Outcome was log10 transformed prior to analyses. |
Title | Tablet Assessment: Visual Spatial Learning Test Number Correct |
---|---|
Description | 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. |
Time Frame | Participants assessed pre-smoking and 1 hour, 2 hours, 4 hours, and 5 hours after smoking |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Placebo | 5.9% THC | 13.4% THC |
---|---|---|---|
Arm/Group Description | Placebo Cannabis | Cannabis with 5.9% THC | Cannabis with 13.4% THC |
Measure Participants | 63 | 66 | 62 |
Pre-smoking |
9.9
(2.3)
|
9.7
(2.7)
|
10.1
(2.2)
|
1 hour |
9.1
(2.8)
|
8.4
(2.6)
|
9.3
(2.7)
|
2 hours |
8.9
(3.1)
|
8.7
(2.6)
|
8.9
(2.7)
|
4 hours |
8.5
(3.0)
|
8.3
(2.9)
|
8.8
(2.5)
|
5 hours |
9.3
(2.9)
|
8.5
(3.0)
|
9.5
(3.0)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, 5.9% THC, 13.4% THC |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | .592 |
Comments | ||
Method | Generalized least squares model | |
Comments | The outcome was transformed using logit function prior to analyses. Model included treatment (3 groups), time (5 times), and their interaction. |
Title | Tablet Assessment: Time Estimation |
---|---|
Description | 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. |
Time Frame | Participants assessed pre-smoking and 1 hour, 2 hours, 4 hours, and 5 hours after smoking |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Placebo | 5.9% THC | 13.4% THC |
---|---|---|---|
Arm/Group Description | Placebo Cannabis | Cannabis with 5.9% THC | Cannabis with 13.4% THC |
Measure Participants | 63 | 66 | 62 |
Pre-smoking |
0.75
(0.19)
|
0.83
(0.30)
|
0.77
(0.22)
|
1 hour |
0.79
(0.21)
|
0.89
(0.30)
|
0.85
(0.24)
|
2 hours |
0.83
(0.20)
|
0.96
(0.30)
|
0.87
(0.27)
|
4 hours |
0.85
(0.23)
|
0.93
(0.23)
|
0.86
(0.21)
|
5 hours |
0.83
(0.20)
|
0.89
(0.28)
|
0.85
(0.21)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, 5.9% THC, 13.4% THC |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | .294 |
Comments | ||
Method | Generalized least squares model | |
Comments |
Title | Tablet Assessment: Balance |
---|---|
Description | 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. |
Time Frame | Participants assessed pre-smoking and 1 hour, 2 hours, 4 hours, and 5 hours after smoking |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Placebo | 5.9% THC | 13.4% THC |
---|---|---|---|
Arm/Group Description | Placebo Cannabis | Cannabis with 5.9% THC | Cannabis with 13.4% THC |
Measure Participants | 63 | 66 | 62 |
Pre-smoking |
0.358
(0.058)
|
0.360
(0.067)
|
0.356
(0.058)
|
1 hour |
0.342
(0.054)
|
0.376
(0.090)
|
0.363
(0.129)
|
2 hours |
0.351
(0.053)
|
0.394
(0.161)
|
0.414
(0.254)
|
4 hours |
0.354
(0.058)
|
0.386
(0.131)
|
0.377
(0.133)
|
5 hours |
0.368
(0.059)
|
0.371
(0.054)
|
0.365
(0.072)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, 5.9% THC, 13.4% THC |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | .144 |
Comments | ||
Method | Generalized least squares model | |
Comments |
Title | THC Concentrations: Correlation Between Blood and Oral Fluid |
---|---|
Description | Spearman's correlation between THC concentrations in whole blood and oral fluid. Higher scores are better. |
Time Frame | Approximately 15 minutes post-smoking |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Placebo | 5.9% THC | 13.4% THC |
---|---|---|---|
Arm/Group Description | Placebo cannabis | Participants smoking 5.9% THC cannabis | Group smoking 13.4% THC |
Measure Participants | 63 | 66 | 62 |
Number (95% Confidence Interval) [Spearman's rho] |
0.217
|
0.414
|
0.249
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | Spearman's correlation | |
Statistical Test of Hypothesis | p-Value | 0.090 |
Comments | ||
Method | Spearman's correlation | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | 5.9% THC |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | Spearman's correlation | |
Statistical Test of Hypothesis | p-Value | .0006 |
Comments | ||
Method | Spearman's correlation | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | 13.4% THC |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | Spearman's correlation | |
Statistical Test of Hypothesis | p-Value | 0.053 |
Comments | ||
Method | Spearman's correlation | |
Comments |
Title | THC Concentrations: Correlation Between Whole Blood and Breath |
---|---|
Description | Spearman's correlation between THC concentrations in whole blood and breath |
Time Frame | Approximately 15 minutes post-smoking |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Placebo | 5.9% THC | 13.4% THC |
---|---|---|---|
Arm/Group Description | Placebo cannabis | Cannabis with 5.9% THC | Cannabis with 13.4% THC |
Measure Participants | 63 | 66 | 62 |
Number (95% Confidence Interval) [Spearman's rho] |
0.134
|
-0.258
|
-0.176
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | Spearman's correlation | |
Statistical Test of Hypothesis | p-Value | 0.300 |
Comments | ||
Method | Spearman's correlation | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | 5.9% THC |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | Spearman's correlation | |
Statistical Test of Hypothesis | p-Value | 0.038 |
Comments | ||
Method | Spearman's correlation | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | 13.4% THC |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | Spearman's correlation | |
Statistical Test of Hypothesis | p-Value | 0.175 |
Comments | ||
Method | Spearman's correlation | |
Comments |
Adverse Events
Time Frame | One day (acute administration) | |||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||
Arm/Group Title | Placebo Cannabis | Cannabis With 5.9% THC | Cannabis With 13.4% THC | |||
Arm/Group Description | Placebo Cannabis (.02% THC) | Cannabis with 5.9% THC, smoked ad libitum | Cannabis with 13.4% THC, smoked ad libitum | |||
All Cause Mortality |
||||||
Placebo Cannabis | Cannabis With 5.9% THC | Cannabis With 13.4% THC | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/65 (0%) | 0/70 (0%) | 0/64 (0%) | |||
Serious Adverse Events |
||||||
Placebo Cannabis | Cannabis With 5.9% THC | Cannabis With 13.4% THC | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/65 (0%) | 0/70 (0%) | 0/64 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
Placebo Cannabis | Cannabis With 5.9% THC | Cannabis With 13.4% THC | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 2/65 (3.1%) | 15/70 (21.4%) | 5/64 (7.8%) | |||
Cardiac disorders | ||||||
Heart Rate Abnormal | 0/65 (0%) | 0 | 12/70 (17.1%) | 12 | 1/64 (1.6%) | 1 |
Gastrointestinal disorders | ||||||
Nausea | 0/65 (0%) | 0 | 2/70 (2.9%) | 2 | 1/64 (1.6%) | 1 |
General disorders | ||||||
Cervicalgia | 0/65 (0%) | 0 | 1/70 (1.4%) | 1 | 0/64 (0%) | 0 |
Fever | 0/65 (0%) | 0 | 1/70 (1.4%) | 1 | 0/64 (0%) | 0 |
Injury, poisoning and procedural complications | ||||||
Discomfort in arm | 1/65 (1.5%) | 1 | 1/70 (1.4%) | 1 | 0/64 (0%) | 0 |
Swollen arm | 0/65 (0%) | 0 | 0/70 (0%) | 0 | 1/64 (1.6%) | 1 |
Numbness in arm | 1/65 (1.5%) | 1 | 0/70 (0%) | 0 | 0/64 (0%) | 0 |
Nervous system disorders | ||||||
Dizziness | 0/65 (0%) | 0 | 3/70 (4.3%) | 3 | 3/64 (4.7%) | 3 |
Sweats | 0/65 (0%) | 0 | 2/70 (2.9%) | 2 | 0/64 (0%) | 0 |
Psychiatric disorders | ||||||
Anxiety | 0/65 (0%) | 0 | 2/70 (2.9%) | 2 | 0/64 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||||
Cough | 0/65 (0%) | 0 | 0/70 (0%) | 0 | 1/64 (1.6%) | 1 |
Vascular disorders | ||||||
Blood Pressure Decreased | 0/65 (0%) | 0 | 3/70 (4.3%) | 3 | 1/64 (1.6%) | 1 |
Blood Pressure Increased | 0/65 (0%) | 0 | 2/70 (2.9%) | 2 | 0/64 (0%) | 0 |
Fainting | 0/65 (0%) | 0 | 1/70 (1.4%) | 1 | 0/64 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Thomas D. Marcotte, Phd |
---|---|
Organization | University of California, San Diego; Center for Medicinal Cannabis Research |
Phone | 619-543-5044 |
tmarcotte@ucsd.edu |
- 160641