Johns Hopkins University School of Medicine
Baltimore, Maryland, 21231, United States
NCT Number: NCT03122691
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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Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Baltimore, Maryland, 21231, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cannabis will be self-administered by study participants
Other names: marijuana
Time frame: 8 hours
Quantitation of active drug (THC) in whole blood (ng/ml).
Time frame: 8 hours
Quantitation of THC metabolite in blood (ng/ml)
Time frame: 8 hours
Quantitation of THC metabolite in blood (ng/ml).
Time frame: Baseline, 1, 2, 3, 4, 5, 6, 7, and 8 hours post drug exposure
Peak change from baseline
Time frame: Up to 5 hours
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.
Time frame: 8 hours
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".
Time frame: 8 hours post drug exposure
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.
Johns Hopkins University
Other
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