Back to resultsPharmacokinetic and Pharmacodynamic Effects of Passive Cannabis Inhalation
Primary Purpose
Cannabis Toxicology
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cannabis
Sponsored by
About this trial
This is an interventional diagnostic trial for Cannabis Toxicology
Eligibility Criteria
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.
Sites / Locations
- Johns Hopkins Behavioral Pharmacology Research Unit
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Cannabis 5% THC, No Ventilation
Cannabis 11% THC, No Ventilation
Cannabis 11% THC, Ventilation
Arm Description
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.
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.
Participants in this condition will be passively exposed to second-hand cannabis smoke from cannabis containing 11% THC in a room with active ventilation.
Outcomes
Primary Outcome Measures
Delta-9-tetrahydrocannabinol (THC) Cmax in Blood
After exposure to cannabis, we will conduct a pharmacokinetic analysis of THC in blood collected.
Secondary Outcome Measures
Delta-9-tetrahydrocannabinol (THC) Cmax in Oral Fluid
After exposure to cannabis, we will conduct a pharmacokinetic analysis of THC in oral fluid.
Subjective VAS Drug Effect
Visual analog scale (0-100; not at all to extremely) of subjective "Drug Effect"
Full Information
NCT ID
NCT01798186
First Posted
February 18, 2013
Last Updated
August 2, 2017
Sponsor
Johns Hopkins University
Collaborators
Substance Abuse and Mental Health Services Administration (SAMHSA), RTI International
1. Study Identification
Unique Protocol Identification Number
NCT01798186
Brief Title
Pharmacokinetic and Pharmacodynamic Effects of Passive Cannabis Inhalation
Official Title
Pharmacokinetic and Pharmacodynamic Effects of Passive Cannabis Inhalation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Substance Abuse and Mental Health Services Administration (SAMHSA), RTI International
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Toxicology
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Between subjects Phase I study
Masking
Participant
Masking Description
Participants are blind to the THC concentrations of cannabis being administered
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cannabis 5% THC, No Ventilation
Arm Type
Experimental
Arm Description
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.
Arm Title
Cannabis 11% THC, No Ventilation
Arm Type
Experimental
Arm Description
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.
Arm Title
Cannabis 11% THC, Ventilation
Arm Type
Experimental
Arm Description
Participants in this condition will be passively exposed to second-hand cannabis smoke from cannabis containing 11% THC in a room with active ventilation.
Intervention Type
Drug
Intervention Name(s)
Cannabis
Other Intervention Name(s)
Marijuana
Intervention Description
Participants will be exposed to cannabis smoke present in ambient air
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Johns Hopkins Behavioral Pharmacology Research Unit
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetic and Pharmacodynamic Effects of Passive Cannabis Inhalation
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