This clinical trial assesses differences in the delivery of THC to the bloodstream depending on whether nicotine vapes are used before or after THC. While there has been much recent publicity about vaping products and concern about their safety considering their increasing use for THC administration, the THC delivery profile associated with THC liquid vaping products in human subjects is currently unknown. Importantly, how the delivery to the bloodstream of THC vaping liquids compare to delivery from smoked cannabis, which is the most used method of cannabis delivery, will serve as an important benchmark for evaluating the delivery and effects of THC vaping products, and their relative safety.
PRIMARY OBJECTIVES: I. Assess pharmacokinetic (PK)/pharmacodynamic (PD) profiles of THC vaping liquids administered with co-use of vaped nicotine. II. Outcomes of interest will be assessed overall, and according to biological sex. SECONDARY OBJECTIVES: I. Safety. II. Assessment of differences in puffing behaviors. III. Short-term subjective drug effects, and cognitive performance following THC use without nicotine versus (vs.) THC use with pre-nicotine use vs. THC use with post-nicotine use in current consumers of both vaped cannabis and vaped nicotine products. OUTLINE: Participants are randomized to 1 of 3 arms. ARM A: Participants complete 3 vaping sessions separated by 7-14 days on study: * VISIT 1: Participants vape placebo nicotine for 10 minutes, followed by THC for 10 minutes, and then placebo nicotine again for 10 minutes. * VISIT 2: Participants vape nicotine for 10 minutes, followed by THC for 10 minutes, and then placebo nicotine for 10 minutes. * VISIT 3: Participants vape placebo nicotine for 10 minutes, followed by THC for 10 minutes, and then nicotine for 10 minutes. ARM B: Participants complete 3 vaping sessions separated by 7-14 days on study: * VISIT 1: Participants vape nicotine for 10 minutes, followed by THC for 10 minutes, and then placebo nicotine for 10 minutes. * VISIT 2: Participants vape placebo nicotine for 10 minutes, followed by THC for 10 minutes, and then nicotine for 10 minutes. * VISIT 3: Participants vape placebo nicotine for 10 minutes, followed by THC for 10 minutes, and then placebo nicotine again for 10 minutes. ARM C: Participants complete 3 vaping sessions separated by 7-14 days on study: * VISIT 1: Participants vape placebo nicotine for 10 minutes, followed by THC for 10 minutes, and then nicotine for 10 minutes. * VISIT 2: Participants vape placebo nicotine for 10 minutes, followed by THC for 10 minutes, and then placebo nicotine again for 10 minutes. * VISIT 3: Participants vape nicotine for 10 minutes, followed by THC for 10 minutes, and then placebo nicotine for 10 minutes. All participants also undergo blood sample collection throughout the trial. After completion of study intervention, participants are followed up at 30 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
60
Undergo blood collection
Vape THC
Vape active nicotine
Vape placebo nicotine
Ancillary studies
Roswell Park Cancer Institute
Buffalo, New York, United States
Maximum concentration of THC in plasma (Cmax)
Pharmacokinetics (PK) profiles of THC in plasma will be determined using a visual plot of plasma THC concentrations by time. Parameters will be derived using non-compartmental analysis in Phoenix WinNonlin and adjusted for baseline THC levels. Will be summarized by nicotine status using the appropriate descriptive statistics and graphical summaries.
Time frame: Up to 21 days
Area under the plasma concentration-time curve from 0-360 minutes (AUC0-360)
Blood samples will be collected for plasma levels of THC. Parameters will be derived using linear mixed models
Time frame: Up to 21 days
Time to maximum concentration of THC in plasma (Tmax)
Blood samples will be collected for plasma levels of THC. Parameters will be derived using linear mixed models.
Time frame: Up to 21 days
Incidence of adverse events (AEs)
AEs will be summarized by nicotine condition and grade using frequencies and relative frequencies. Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting.
Time frame: Up to 30 days after completion of study intervention
Puffing behaviors
puff duration
Time frame: Up to 21 days
Puffing behaviors
puff number
Time frame: Up to 21 days
Short-term drug effects
The short-term drug effects (Drug Effects Questionnaire \[DEQ), The DEQ rates sixteen component items using a visual analog scale (0-100) to examine drug effects pre- and post-use
Time frame: Up to 21 days
Marijuana Withdrawal Checklist [MWC)
The Marijuana Withdrawal Questionnaire Total Score includes items assessing anxiety, depression, irritability, appetite, aggression/anger, sleep disturbance, somatic disturbances, and craving to use marijuana. The potential range of this total score is from "0" = no withdrawal symptoms to "47" = maximally high levels of withdrawal
Time frame: Up to 21 days
Digit Symbol Substitution Task (DSST)
An assessment of cognitive dysfunction that test ability to complete daily tasks
Time frame: Up to 21 days
Paced Auditory Serial Addition Task (PASET)
Measures of working memory and concentration .
Time frame: Up to 21 days
Tobacco Craving Questionnaire (Short Form)
Self reported 47-item questionnaire that assesses tobacco craving. Items are rated on a Likert-type scale from 1 (strongly disagree) to 7 (strongly agree). Factor scores for each participant are obtained by summing the three items in each factor scale, yielding a score ranging from 3 to 21.
Time frame: Up to 21 days
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