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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-DN-BX-0193 | Other Grant/Funding Number | National Institute of Justice | |
| R44DA046272-01A1 | U.S. NIH Grant/Contract | View source | |
| T32DA007209 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| RTI International | OTHER |
| U.S. Department of Justice | FED |
| National Institute on Drug Abuse (NIDA) | NIH |
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This research is being done to measure the effects of both oral and vaporized cannabis (marijuana), at different doses, on the ability to perform certain tasks such as balancing, eye tracking, and computerized measures of memory and attention, as well as performance on a novel app (DRUID) that is being developed for field sobriety testing. The investigators will collect biological fluids (urine, blood, saliva/spit) after cannabis is eaten or vaporized to see if there are markers in those fluids that can predict performance on the behavioral tasks and the DRUID App. The results of this study will help us better understand the effects of using cannabis, and to help identify behaviors and/or substances in the body that relate to cannabis impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Oral Cannabis | Placebo Comparator | Single acute administration of placebo cannabis baked into a brownie |
|
| Low-Dose Oral Cannabis | Experimental | Single acute administration of cannabis containing 10mg THC baked into a brownie |
|
| High-Dose Oral Cannabis | Experimental | Single acute administration of cannabis containing 25mg THC baked into a brownie |
|
| Placebo Vaporized Cannabis | Placebo Comparator | Single acute administration of placebo cannabis via commercial vaporizer |
|
| Low-Dose Vaporized Cannabis | Experimental | Single acute administration of placebo cannabis containing 5mg THC via commercial vaporizer |
|
| High-Dose Vaporized Cannabis | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cannabis | Drug | Cannabis will be self-administered by study participants |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tetrahydrocannabinol (THC) Concentration in Blood | Quantitation of active drug (THC) in whole blood (ng/ml). | 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 11-hydroxy-tetrahydrocannabinol (11-OH-THC) | Quantitation of THC metabolite in blood (ng/ml) | 8 hours |
| Tetrahydrocannabinolic Acid (THCCOOH) | Quantitation of THC metabolite in blood (ng/ml). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Vandrey, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21231 | United States |
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This was a within-subjects design, so all participants were exposed to all six conditions in a randomized order.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Cannabis 0mg, 10mg, 25mg; Vaporized Cannabis 0mg, 5mg, 20mg | Participants ingested and vaporized THC in the above order in a within-subject crossover design |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Evaluable Study Completers | Participants received oral (0, 10, 25mg) and vaporized (0mg, 5, 20mg) THC in a randomized within-subject crossover design |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Tetrahydrocannabinol (THC) Concentration in Blood | Quantitation of active drug (THC) in whole blood (ng/ml). | This was a within-subjects design, so all participants were exposed to all six conditions in a randomized order. | Posted | Mean | Standard Deviation | ng/ml | 8 hours |
|
1 year, 1 month
This was a within-subjects cross-over design. All participants were exposed to all six dose conditions. Exposure was clustered by route of administration (oral vs vaporized) and doses within each route were administered in a randomized order.
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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 | Placebo Oral Cannabis | Single acute administration of placebo cannabis baked into a brownie |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ryan Vandrey | Johns Hopkins University School of Medicine | 410-550-4036 | rvandrey@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 18, 2018 | Oct 26, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 5, 2018 | Oct 26, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| C587251 | nabiximols |
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Placebo controlled, double blind drug administration
Single acute administration of placebo cannabis containing 20mg THC via commercial vaporizer
|
|
| 8 hours |
| Change in Heart Rate | Peak change from baseline | Baseline, 1, 2, 3, 4, 5, 6, 7, and 8 hours post drug exposure |
| Mean (SD) Peak Change-from-baseline Drug Effect Rating | Subjective rating of drug effect (0-100) at peak effect: between 2 and 5 hours for oral dosing conditions and 0 and 2 hours for vaporized conditions. Higher numbers mean stronger drug effects, where 0 means no drug effect and 100 means extremely strong drug effect. | Up to 5 hours |
| Change From Baseline Behavioral Task Performance as Assessed by the DRUID App Score | Composite Global Impairment Score on the DRUID (DRiving Under the Influence of Drugs) App, a measure of behavioral task performance (range 0-100) where lower scores indicate better performance. ≥13-point change (from baseline) on DRUID global impairment score = "impaired"; <13-point change (from baseline) = "not impaired". | 8 hours |
| Peak Change in Blood Pressure | Systolic and Diastolic blood pressure will be measured at baseline and repeatedly for 8 hours after drug exposure. Outcome is the peak change from baseline assessed within the 8 hour period of assessment. | 8 hours post drug exposure |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG002 | High-Dose Oral Cannabis | Single acute administration of cannabis containing 25mg THC baked into a brownie cannabis: Cannabis will be self-administered by study participants |
| OG003 | Placebo Vaporized Cannabis | Single acute administration of placebo cannabis via commercial vaporizer cannabis: Cannabis will be self-administered by study participants |
| OG004 | Low-Dose Vaporized Cannabis | Single acute administration of placebo cannabis containing 5mg THC via commercial vaporizer cannabis: Cannabis will be self-administered by study participants |
| OG005 | High-Dose Vaporized Cannabis | Single acute administration of placebo cannabis containing 20mg THC via commercial vaporizer cannabis: Cannabis will be self-administered by study participants |
|
|
| Secondary | 11-hydroxy-tetrahydrocannabinol (11-OH-THC) | Quantitation of THC metabolite in blood (ng/ml) | This was a within-subjects design, so all participants were exposed to all six conditions in a randomized order. | Posted | Mean | Standard Deviation | ng/mL | 8 hours |
|
|
|
| Secondary | Tetrahydrocannabinolic Acid (THCCOOH) | Quantitation of THC metabolite in blood (ng/ml). | This was a within-subjects design, so all participants were exposed to all six conditions in a randomized order. | Posted | Mean | Standard Deviation | ng/mL | 8 hours |
|
|
|
| Secondary | Change in Heart Rate | Peak change from baseline | This was a within-subjects design, so all participants were exposed to all six conditions in a randomized order. | Posted | Mean | Standard Deviation | Beats per minute | Baseline, 1, 2, 3, 4, 5, 6, 7, and 8 hours post drug exposure |
|
|
|
| Secondary | Mean (SD) Peak Change-from-baseline Drug Effect Rating | Subjective rating of drug effect (0-100) at peak effect: between 2 and 5 hours for oral dosing conditions and 0 and 2 hours for vaporized conditions. Higher numbers mean stronger drug effects, where 0 means no drug effect and 100 means extremely strong drug effect. | This was a within-subjects design, so all participants were exposed to all six conditions in a randomized order. | Posted | Mean | Standard Deviation | Score on a scale | Up to 5 hours |
|
|
|
| Secondary | Change From Baseline Behavioral Task Performance as Assessed by the DRUID App Score | Composite Global Impairment Score on the DRUID (DRiving Under the Influence of Drugs) App, a measure of behavioral task performance (range 0-100) where lower scores indicate better performance. ≥13-point change (from baseline) on DRUID global impairment score = "impaired"; <13-point change (from baseline) = "not impaired". | This was a within-subjects design, so all participants were exposed to all six conditions in a randomized order. | Posted | Mean | Standard Deviation | score on a scale | 8 hours |
|
|
|
| Secondary | Peak Change in Blood Pressure | Systolic and Diastolic blood pressure will be measured at baseline and repeatedly for 8 hours after drug exposure. Outcome is the peak change from baseline assessed within the 8 hour period of assessment. | This was a within-subjects design, so all participants were exposed to all six conditions in a randomized order. | Posted | Mean | Standard Deviation | mm/Hg | 8 hours post drug exposure |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Low-Dose Oral Cannabis | Single acute administration of cannabis containing 10mg THC baked into a brownie | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | High-Dose Oral Cannabis | Single acute administration of cannabis containing 25mg THC baked into a brownie | 0 | 20 | 0 | 20 | 0 | 20 |
| EG003 | Placebo Vaporized Cannabis | Single acute administration of placebo cannabis via commercial vaporizer | 0 | 20 | 0 | 20 | 0 | 20 |
| EG004 | Low-Dose Vaporized Cannabis | Single acute administration of placebo cannabis containing 5mg THC via commercial vaporizer | 0 | 20 | 0 | 20 | 0 | 20 |
| EG005 | High-Dose Vaporized Cannabis | Single acute administration of placebo cannabis containing 20mg THC via commercial vaporizer | 0 | 20 | 0 | 20 | 0 | 20 |
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| Diastolic BP |
|