Vaping Clinical Trial
Official title:
Characterization of the Pharmacodynamic Response to Vaped THC
This study aims to characterize the pharmacodynamic response to vaped THC in young adult, occasional cannabis users with respect to outcomes such as stimulation and sedative effects, mood, anxiety, and craving, as well as cognitive and objective outcomes such as heart rate and cortisol changes with THC vs placebo.
Enrollees will include 120 healthy, weekly or greater MJ users, aged 18-55. The study will be conducted according to a double-blind, placebo-controlled, random order, cross-over design, consisting of one 3-hour screening visit and 2 randomized, approximately 6-hour laboratory sessions. At the latter visits (following confirmation of eligibility), subjects will complete baseline questionnaires and assessments, including a driver simulator test, a blood draw, vitals, and an imaging session using functional near-infrared spectroscopy (fNIRS). Subjects will then vape a first dose (either THC or placebo based on randomization). Vitals and questionnaires will then be administered throughout the visit, at baseline, and at approximately 15, 60, 90, 130, 165, and 210 minutes post initial dose. Subjects will also perform fNIRS testing at baseline, 30, and 180 minutes and driver simulator at baseline, 60, and 90 minutes post initial THC/placebo administration. A drug recognition expert (DRE) will conduct a standard field sobriety test to identify impairment at approximately 130 minutes post dose. Following the initial dose vaped at 0 minutes, standardized reduced doses will be vaped approximately 30, 60, and 90 minutes later. Given the cross-over design of this study, participants will be assigned to receive THC or placebo at the first laboratory visit and will receive the other substance at the second laboratory visit. ;
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