Acute Effects of Sequential Nicotine Vaping on the Pharmacokinetic and Pharmacodynamic Properties of Vaped THC: A Double-Blind, Placebo-Controlled, Randomized Within-Subject Crossover Study
Roswell Park Cancer Institute
Summary
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.
Description
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…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Age ≥ 21 years of age; (self-reported on screening, verified at study visit). * Report use of commercial THC vaping cartridges for at least 3 months prior to enrollment; (self-reported). * Experience with THC potency at or above the study product AND experience with chasing THC with nicotine (at least monthly); (self-reported). * Report use of THC vaping liquids at least weekly (4x/month); (self-reported). * Daily use of nicotine vaping products containing 5% nicotine for at least 3 months prior to enrollment; (self-reported). * Report of not currently trying to become p…
Interventions
- ProcedureBiospecimen Collection
Undergo blood collection
- DrugCannabis sativa Extract
Vape THC
- DrugNicotine
Vape active nicotine
- DrugPlacebo Administration
Vape placebo nicotine
- OtherQuestionnaire Administration
Ancillary studies
Location
- Roswell Park Cancer InstituteBuffalo, New York