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| Name | Class |
|---|---|
| Substance Abuse and Mental Health Services Administration (SAMHSA) | FED |
| RTI International | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cannabis 5% THC, No Ventilation | Experimental | 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. |
|
| Cannabis 11% THC, No Ventilation | Experimental | 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. |
|
| Cannabis 11% THC, Ventilation | Experimental | Participants in this condition will be passively exposed to second-hand cannabis smoke from cannabis containing 11% THC in a room with active ventilation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabis | Drug | Participants will be exposed to cannabis smoke present in ambient air |
|
| Measure | Description | Time Frame |
|---|---|---|
| Delta-9-tetrahydrocannabinol (THC) Cmax in Blood | After exposure to cannabis, we will conduct a pharmacokinetic analysis of THC in blood 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Delta-9-tetrahydrocannabinol (THC) Cmax in Oral Fluid | After exposure to cannabis, we will conduct a pharmacokinetic analysis of THC 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 |
| Subjective VAS Drug Effect |
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Participants must:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Behavioral Pharmacology Research Unit | Baltimore | Maryland | 21224 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cannabis 5% THC, no Ventilation | passive exposure to 5% THC in an unventilated room |
| FG001 | Cannabis 11% THC, no Ventilation | passive exposure to 11% THC cannabis smoke in an unventilated room |
| FG002 | Cannabis 11% THC, Ventilated | passive exposure to 11% THC cannabis smoke in a room with active air ventilation |
| FG003 | Active Smokers | Participants that smoked cannabis |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cannabis 5% THC, no Vent | passive exposure to 5% THC cannabis smoke, unventilated room |
| BG001 | Cannabis 11% THC, no Vent | passive exposure to 11% THC cannabis smoke, unventilated room |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Delta-9-tetrahydrocannabinol (THC) Cmax in Blood | After exposure to cannabis, we will conduct a pharmacokinetic analysis of THC in blood collected. | Posted | Mean | Standard Deviation | ng/mL | 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 22, 26, 30, and 34 hours post cannabis exposure |
|
2 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 5% THC Cannabis Smoke, no Ventilation | passive exposure to 5%THC cannabis smoke in unventilated room |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ryan Vandrey | Johns Hopkins University | 410-550-4036 | rvandrey@jhmi.edu |
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| ID | Term |
|---|---|
| C587251 | nabiximols |
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Between subjects Phase I study
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Participants are blind to the THC concentrations of cannabis being administered
|
Visual analog scale (0-100; not at all to extremely) of subjective "Drug Effect" |
| immediately post cannabis exposure. |
| BG002 | Cannabis 11% THC, Vent | passive exposure to 11% THC cannabis smoke, ventilated room |
| BG003 | Smokers | cannabis smokers |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
passive exposure to 11% THC cannabis smoke in ventilated room |
|
|
| Secondary | Delta-9-tetrahydrocannabinol (THC) Cmax in Oral Fluid | After exposure to cannabis, we will conduct a pharmacokinetic analysis of THC in oral fluid. | Posted | Mean | Full Range | ng/mL | 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 |
|
|
|
| Secondary | Subjective VAS Drug Effect | Visual analog scale (0-100; not at all to extremely) of subjective "Drug Effect" | Posted | Mean | Standard Deviation | mm | immediately post cannabis exposure. |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | 11% THC Cannabis Smoke, no Ventilation | passive exposure to 11%THC cannabis smoke in unventilated room | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | 11% THC Cannabis Smoke, Ventilation | passive exposure to 11%THC cannabis smoke in ventilated room | 0 | 6 | 0 | 6 | 0 | 6 |
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