Cannabis Toxicology
Conditions
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.
Interventions
DRUGCannabis
Participants will be exposed to cannabis smoke present in ambient air
Sponsors
Substance Abuse and Mental Health Services Administration (SAMHSA)
RTI International
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Masking description
Participants are blind to the THC concentrations of cannabis being administered
Intervention model description
Between subjects Phase I study
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Subjective VAS Drug Effect | immediately post cannabis exposure. | Visual analog scale (0-100; not at all to extremely) of subjective Drug Effect |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Cannabis 5% THC, no Vent passive exposure to 5% THC cannabis smoke, unventilated room | 6 |
| Cannabis 11% THC, no Vent passive exposure to 11% THC cannabis smoke, unventilated room | 6 |
| Cannabis 11% THC, Vent passive exposure to 11% THC cannabis smoke, ventilated room | 6 |
| Smokers cannabis smokers | 8 |
| Total | 26 |
Baseline characteristics
| Characteristic | Cannabis 5% THC, no Vent | Total | Smokers | Cannabis 11% THC, Vent | Cannabis 11% THC, no Vent |
|---|---|---|---|---|---|
| Age, Continuous | 25 years STANDARD_DEVIATION 3 | 28 years STANDARD_DEVIATION 7 | 29 years STANDARD_DEVIATION 6 | 30 years STANDARD_DEVIATION 8 | 29 years STANDARD_DEVIATION 9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 3 Participants | 1 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 23 Participants | 7 Participants | 4 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 5 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 18 Participants | 5 Participants | 5 Participants | 5 Participants |
| Region of Enrollment United States | 6 participants | 18 participants | 8 participants | 6 participants | 6 participants |
| Sex: Female, Male Female | 3 Participants | 12 Participants | 3 Participants | 3 Participants | 3 Participants |
| Sex: Female, Male Male | 3 Participants | 14 Participants | 5 Participants | 3 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 |
Outcome results
Primary
Delta-9-tetrahydrocannabinol (THC) Cmax in Blood
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5% THC Cannabis, no Vent | Delta-9-tetrahydrocannabinol (THC) Cmax in Blood | 1.4 ng/mL | Standard Deviation 0.5 |
| 11% THC Cannabis Smoke, no Vent | Delta-9-tetrahydrocannabinol (THC) Cmax in Blood | 3.07 ng/mL | Standard Deviation 1.6 |
| 11% THC Cannabis, Vent | Delta-9-tetrahydrocannabinol (THC) Cmax in Blood | 0.5 ng/mL | Standard Deviation 0.4 |
Secondary
Delta-9-tetrahydrocannabinol (THC) Cmax in Oral Fluid
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 5% THC Cannabis, no Vent | Delta-9-tetrahydrocannabinol (THC) Cmax in Oral Fluid | 34 ng/mL |
| 11% THC Cannabis Smoke, no Vent | Delta-9-tetrahydrocannabinol (THC) Cmax in Oral Fluid | 82 ng/mL |
| 11% THC Cannabis, Vent | Delta-9-tetrahydrocannabinol (THC) Cmax in Oral Fluid | 17 ng/mL |
Secondary
Subjective VAS Drug Effect
Visual analog scale (0-100; not at all to extremely) of subjective Drug Effect
Time frame: immediately post cannabis exposure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5% THC Cannabis, no Vent | Subjective VAS Drug Effect | 6 mm | Standard Deviation 5 |
| 11% THC Cannabis Smoke, no Vent | Subjective VAS Drug Effect | 23 mm | Standard Deviation 13 |
| 11% THC Cannabis, Vent | Subjective VAS Drug Effect | 3 mm | Standard Deviation 4 |