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Pharmacokinetic and Pharmacodynamic Effects of Passive Cannabis Inhalation

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ClinicalTrials.gov Identifier: NCT01798186
Recruitment Status : Completed
First Posted : February 25, 2013
Results First Posted : August 3, 2017
Last Update Posted : August 3, 2017
Sponsor:
Collaborators:
Substance Abuse and Mental Health Services Administration (SAMHSA)
RTI International
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Diagnostic
Condition Cannabis Toxicology
Intervention Drug: Cannabis
Enrollment 26
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Cannabis 5% THC, no Ventilation Cannabis 11% THC, no Ventilation Cannabis 11% THC, Ventilated Active Smokers
Hide Arm/Group Description passive exposure to 5% THC in an unventilated room passive exposure to 11% THC cannabis smoke in an unventilated room passive exposure to 11% THC cannabis smoke in a room with active air ventilation Participants that smoked cannabis
Period Title: Overall Study
Started 6 6 6 8
Completed 6 6 6 8
Not Completed 0 0 0 0
Arm/Group Title Cannabis 5% THC, no Vent Cannabis 11% THC, no Vent Cannabis 11% THC, Vent Smokers Total
Hide Arm/Group Description passive exposure to 5% THC cannabis smoke, unventilated room passive exposure to 11% THC cannabis smoke, unventilated room passive exposure to 11% THC cannabis smoke, ventilated room cannabis smokers Total of all reporting groups
Overall Number of Baseline Participants 6 6 6 8 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 6 participants 8 participants 26 participants
25  (3) 29  (9) 30  (8) 29  (6) 28  (7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 8 participants 26 participants
Female
3
  50.0%
3
  50.0%
3
  50.0%
3
  37.5%
12
  46.2%
Male
3
  50.0%
3
  50.0%
3
  50.0%
5
  62.5%
14
  53.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 8 participants 26 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
2
  33.3%
1
  12.5%
3
  11.5%
Not Hispanic or Latino
6
 100.0%
6
 100.0%
4
  66.7%
7
  87.5%
23
  88.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 8 participants 26 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  33.3%
1
  16.7%
0
   0.0%
2
  25.0%
5
  19.2%
White
3
  50.0%
5
  83.3%
5
  83.3%
5
  62.5%
18
  69.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
  16.7%
1
  12.5%
2
   7.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 6 participants 6 participants 8 participants 26 participants
6 6 6 8 18
1.Primary Outcome
Title Delta-9-tetrahydrocannabinol (THC) Cmax in Blood
Hide Description After exposure to cannabis, we will conduct a pharmacokinetic analysis of THC in blood collected.
Time Frame 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 22, 26, 30, and 34 hours post cannabis exposure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 5% THC Cannabis, no Vent 11% THC Cannabis Smoke, no Vent 11% THC Cannabis, Vent
Hide Arm/Group Description:
passive exposure to 5%THC cannabis smoke in unventilated room
passive exposure to 11% THC cannabis smoke in unventilated room
passive exposure to 11% THC cannabis smoke in ventilated room
Overall Number of Participants Analyzed 6 6 6
Mean (Standard Deviation)
Unit of Measure: ng/mL
1.4  (0.5) 3.07  (1.6) 0.5  (0.4)
2.Secondary Outcome
Title Delta-9-tetrahydrocannabinol (THC) Cmax in Oral Fluid
Hide Description After exposure to cannabis, we will conduct a pharmacokinetic analysis of THC in oral fluid.
Time Frame 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 exposure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 5%THC Cannabis, no Ventilation 11%THC Cannabis, no Ventilation 11% THC Cannabis, no Ventilation
Hide Arm/Group Description:
passive exposure to 5% THC cannabis smoke, no room ventilation
passive exposure to 11% THC cannabis smoke, no room ventilation
passive exposure to 5% THC cannabis smoke, with active room ventilation
Overall Number of Participants Analyzed 6 6 6
Mean (Full Range)
Unit of Measure: ng/mL
34
(5 to 86)
82
(12 to 308)
17
(2 to 75)
3.Secondary Outcome
Title Subjective VAS Drug Effect
Hide Description Visual analog scale (0-100; not at all to extremely) of subjective "Drug Effect"
Time Frame immediately post cannabis exposure.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 5%THC, no Vent 11% THC Cannabis Smoke, no Vent 11% THC Cannabis, Ventilated
Hide Arm/Group Description:
passive 5% THC cannabis smoke, no room ventilation
passive exposure to 11% THC cannabis smoke in unventilated room
passive exposure to 11% THC cannabis smoke in ventilated room
Overall Number of Participants Analyzed 6 6 6
Mean (Standard Deviation)
Unit of Measure: mm
6  (5) 23  (13) 3  (4)
Time Frame 2 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 5% THC Cannabis Smoke, no Ventilation 11% THC Cannabis Smoke, no Ventilation 11% THC Cannabis Smoke, Ventilation
Hide Arm/Group Description passive exposure to 5%THC cannabis smoke in unventilated room passive exposure to 11%THC cannabis smoke in unventilated room passive exposure to 11%THC cannabis smoke in ventilated room
All-Cause Mortality
5% THC Cannabis Smoke, no Ventilation 11% THC Cannabis Smoke, no Ventilation 11% THC Cannabis Smoke, Ventilation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
5% THC Cannabis Smoke, no Ventilation 11% THC Cannabis Smoke, no Ventilation 11% THC Cannabis Smoke, Ventilation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
5% THC Cannabis Smoke, no Ventilation 11% THC Cannabis Smoke, no Ventilation 11% THC Cannabis Smoke, Ventilation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%) 
Certain Agreements
Principal Investigators are NOT 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: Ryan Vandrey
Organization: Johns Hopkins University
Phone: 410-550-4036
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01798186     History of Changes
Other Study ID Numbers: NA_00082269
First Submitted: February 18, 2013
First Posted: February 25, 2013
Results First Submitted: April 17, 2017
Results First Posted: August 3, 2017
Last Update Posted: August 3, 2017