Trial Outcomes & Findings for Pharmacokinetic and Pharmacodynamic Effects of Passive Cannabis Inhalation (NCT NCT01798186)
NCT ID: NCT01798186
Last Updated: 2017-08-03
Results Overview
After exposure to cannabis, we will conduct a pharmacokinetic analysis of THC in blood collected.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 22, 26, 30, and 34 hours post cannabis exposure
Results posted on
2017-08-03
Participant Flow
Participants were randomized to 3 experimental sessions. Additionally, participants were recruited to smoke cannabis in order to generate the smoke that was passively inhaled by the experimental groups.
Participant milestones
| Measure |
Cannabis 5% THC, no Ventilation
passive exposure to 5% THC in an unventilated room
|
Cannabis 11% THC, no Ventilation
passive exposure to 11% THC cannabis smoke in an unventilated room
|
Cannabis 11% THC, Ventilated
passive exposure to 11% THC cannabis smoke in a room with active air ventilation
|
Active Smokers
Participants that smoked cannabis
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
8
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetic and Pharmacodynamic Effects of Passive Cannabis Inhalation
Baseline characteristics by cohort
| Measure |
Cannabis 5% THC, no Vent
n=6 Participants
passive exposure to 5% THC cannabis smoke, unventilated room
|
Cannabis 11% THC, no Vent
n=6 Participants
passive exposure to 11% THC cannabis smoke, unventilated room
|
Cannabis 11% THC, Vent
n=6 Participants
passive exposure to 11% THC cannabis smoke, ventilated room
|
Smokers
n=8 Participants
cannabis smokers
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
25 years
STANDARD_DEVIATION 3 • n=5 Participants
|
29 years
STANDARD_DEVIATION 9 • n=7 Participants
|
30 years
STANDARD_DEVIATION 8 • n=5 Participants
|
29 years
STANDARD_DEVIATION 6 • n=4 Participants
|
28 years
STANDARD_DEVIATION 7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
8 participants
n=4 Participants
|
18 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 22, 26, 30, and 34 hours post cannabis exposureAfter exposure to cannabis, we will conduct a pharmacokinetic analysis of THC in blood collected.
Outcome measures
| Measure |
5% THC Cannabis, no Vent
n=6 Participants
passive exposure to 5%THC cannabis smoke in unventilated room
|
11% THC Cannabis Smoke, no Vent
n=6 Participants
passive exposure to 11% THC cannabis smoke in unventilated room
|
11% THC Cannabis, Vent
n=6 Participants
passive exposure to 11% THC cannabis smoke in ventilated room
|
|---|---|---|---|
|
Delta-9-tetrahydrocannabinol (THC) Cmax in Blood
|
1.4 ng/mL
Standard Deviation 0.5
|
3.07 ng/mL
Standard Deviation 1.6
|
0.5 ng/mL
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Samples collected 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 22, 26, 30, and 34 hours post cannabis exposureAfter exposure to cannabis, we will conduct a pharmacokinetic analysis of THC in oral fluid.
Outcome measures
| Measure |
5% THC Cannabis, no Vent
n=6 Participants
passive exposure to 5%THC cannabis smoke in unventilated room
|
11% THC Cannabis Smoke, no Vent
n=6 Participants
passive exposure to 11% THC cannabis smoke in unventilated room
|
11% THC Cannabis, Vent
n=6 Participants
passive exposure to 11% THC cannabis smoke in ventilated room
|
|---|---|---|---|
|
Delta-9-tetrahydrocannabinol (THC) Cmax in Oral Fluid
|
34 ng/mL
Interval 5.0 to 86.0
|
82 ng/mL
Interval 12.0 to 308.0
|
17 ng/mL
Interval 2.0 to 75.0
|
SECONDARY outcome
Timeframe: immediately post cannabis exposure.Visual analog scale (0-100; not at all to extremely) of subjective "Drug Effect"
Outcome measures
| Measure |
5% THC Cannabis, no Vent
n=6 Participants
passive exposure to 5%THC cannabis smoke in unventilated room
|
11% THC Cannabis Smoke, no Vent
n=6 Participants
passive exposure to 11% THC cannabis smoke in unventilated room
|
11% THC Cannabis, Vent
n=6 Participants
passive exposure to 11% THC cannabis smoke in ventilated room
|
|---|---|---|---|
|
Subjective VAS Drug Effect
|
6 mm
Standard Deviation 5
|
23 mm
Standard Deviation 13
|
3 mm
Standard Deviation 4
|
Adverse Events
5% THC Cannabis Smoke, no Ventilation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
11% THC Cannabis Smoke, no Ventilation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
11% THC Cannabis Smoke, Ventilation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place