Pharmacokinetic and Pharmacodynamic Effects of Passive Cannabis Inhalation

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01798186
• Collaborator: Substance Abuse and Mental Health Services Administration (SAMHSA) (U.S. Fed), RTI International (Other)
• Enrollment: 26
• Location: 1
• Arms: 3
• Duration (Months): 3
• Patients Per Site Per Month: 8.6

Study Details

Study Description

Brief Summary

This primary aim of this study is to assess the effects of passive (second-hand) inhalation of cannabis smoke on toxicological analysis of "native" oral fluid (saliva), urine and blood specimens. The results of this study will help inform the validity of oral fluid as a biomarker of cannabis exposure and to determine whether, and for how long, passive inhalation of cannabis smoke could result in a positive toxicology result.

Condition or Disease	Intervention/Treatment	Phase
Cannabis Toxicology	Drug: Cannabis	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Between subjects Phase I studyBetween subjects Phase I study
• Masking: Single (Participant)
• Masking Description: Participants are blind to the THC concentrations of cannabis being administered
• Primary Purpose: Diagnostic
• Official Title: Pharmacokinetic and Pharmacodynamic Effects of Passive Cannabis Inhalation
• Study Start Date: May 1, 2013
• Actual Primary Completion Date: Aug 1, 2013
• Actual Study Completion Date: Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cannabis 5% THC, No Ventilation Participants in this condition will be passively exposed to second-hand cannabis smoke from cannabis containing 5% THC and in a room with no ventilation.	Drug: Cannabis; Participants will be exposed to cannabis smoke present in ambient air; Other Names: Marijuana
Experimental: Cannabis 11% THC, No Ventilation Participants in this condition will be passively exposed to second-hand cannabis smoke from cannabis containing 11% THC and in a room with no ventilation.	Drug: Cannabis; Participants will be exposed to cannabis smoke present in ambient air; Other Names: Marijuana
Experimental: Cannabis 11% THC, Ventilation Participants in this condition will be passively exposed to second-hand cannabis smoke from cannabis containing 11% THC in a room with active ventilation.	Drug: Cannabis; Participants will be exposed to cannabis smoke present in ambient air; Other Names: Marijuana

Outcome Measures

Primary Outcome Measures

1. Delta-9-tetrahydrocannabinol (THC) Cmax in Blood [0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 22, 26, 30, and 34 hours post cannabis exposure]

   After exposure to cannabis, we will conduct a pharmacokinetic analysis of THC in blood collected.

Secondary Outcome Measures

1. Delta-9-tetrahydrocannabinol (THC) Cmax in Oral Fluid [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]

   After exposure to cannabis, we will conduct a pharmacokinetic analysis of THC in oral fluid.

2. Subjective VAS Drug Effect [immediately post cannabis exposure.]

   Visual analog scale (0-100; not at all to extremely) of subjective "Drug Effect"

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Participants must:

• Be between the ages of 18 and 45

• Be in good general health based on a physical examination, medical history, vital signs, 12-lead ECG and screening urine and blood tests

• Demonstrate ability to expectorate 3-5 mL of "native" oral fluid over a 5-minute period

• Be willing and able to abstain from use of any over-the-counter (OTC) or prescription drugs (other than birth control medications) after providing written informed consent and continuing until discharged from the study. OTC antacids may be taken up to 12 hours prior to dosing

• Not be pregnant or nursing (if female), and using effective birth control. All females must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at clinic admission.

• Have a body mass index (BMI) in the range of 19 to 33 kg/m2

• Have head hair that is at least 4-6 cm (approximately two inches) in length on the back of the head.

• Blood pressure at Screening Visit must not exceed a systolic blood pressure (SBP) of 140 mmHg or a diastolic blood pressure (DBP) of 90 mmHg

• Must not have history of significant medical or psychiatric illness judged by the investigator to put the participant at greater risk of experiencing an adverse event due to exposure or completion of other study procedures.

• Cannot have been enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing.

• No history of panic/anxiety reaction to extended periods of confinement in close quarters, smoke filled areas, or tight social situations.

• No history of adverse reactions to cannabis exposure, whether via direct use or passive exposure.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins Behavioral Pharmacology Research Unit	Baltimore	Maryland	United States	21224

Sponsors and Collaborators

• Johns Hopkins University
• Substance Abuse and Mental Health Services Administration (SAMHSA)
• RTI International

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT01798186
• Other Study ID Numbers: NA_00082269
• First Posted: Feb 25, 2013
• Last Update Posted: Aug 3, 2017
• Last Verified: Aug 1, 2017

• Additional relevant MeSH terms: Marijuana Abuse

Study Results

Participant Flow

Pre-assignment Detail	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
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

Baseline Characteristics

Arm/Group Title	Cannabis 5% THC, no Vent	Cannabis 11% THC, no Vent	Cannabis 11% THC, Vent	Smokers	Total
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 Participants	6	6	6	8	26
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	25 (3)	29 (9)	30 (8)	29 (6)	28 (7)
Sex: Female, Male (Count of Participants)
Female	3 50%	3 50%	3 50%	3 37.5%	12 46.2%
Male	3 50%	3 50%	3 50%	5 62.5%	14 53.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	2 33.3%	1 12.5%	3 11.5%
Not Hispanic or Latino	6 100%	6 100%	4 66.7%	7 87.5%	23 88.5%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	1 16.7%	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%
Black or African American	2 33.3%	1 16.7%	0 0%	2 25%	5 19.2%
White	3 50%	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%
Unknown or Not Reported	0 0%	0 0%	1 16.7%	1 12.5%	2 7.7%
Region of Enrollment (participants) [Number]
United States	6 100%	6 100%	6 100%	8 100%	18 69.2%

Outcome Measures

1. Primary Outcome

Title	Delta-9-tetrahydrocannabinol (THC) Cmax in Blood
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5% THC Cannabis, no Vent	11% THC Cannabis Smoke, no Vent	11% THC Cannabis, Vent
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
Measure Participants	6	6	6
Mean (Standard Deviation) [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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5%THC Cannabis, no Ventilation	11%THC Cannabis, no Ventilation	11% THC Cannabis, no Ventilation
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
Measure Participants	6	6	6
Mean (Full Range) [ng/mL]	34	82	17

3. Secondary Outcome

Title	Subjective VAS Drug Effect
Description	Visual analog scale (0-100; not at all to extremely) of subjective "Drug Effect"
Time Frame	immediately post cannabis exposure.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5%THC, no Vent	11% THC Cannabis Smoke, no Vent	11% THC Cannabis, Ventilated
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
Measure Participants	6	6	6
Mean (Standard Deviation) [mm]	6 (5)	23 (13)	3 (4)

Adverse Events

Time Frame	2 days
Arm/Group Title	5% THC Cannabis Smoke, no Ventilation		11% THC Cannabis Smoke, no Ventilation		11% THC Cannabis Smoke, Ventilation
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)		0/6 (0%)
Serious Adverse Events
	5% THC Cannabis Smoke, no Ventilation		11% THC Cannabis Smoke, no Ventilation		11% THC Cannabis Smoke, Ventilation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	5% THC Cannabis Smoke, no Ventilation		11% THC Cannabis Smoke, no Ventilation		11% THC Cannabis Smoke, Ventilation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)		0/6 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.