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Clinical Trial Summary

The purpose of this study is to measure the individual and combined influence of electronic cigarette (ECIG) heating element resistance and liquid nicotine concentration on ECIG acute effects. Thirty-two experienced ECIG users will complete four independent laboratory sessions that will differ by heater resistance (0.5 ohm or 1.5 ohm) and liquid nicotine concentration (3 or 8 mg/ml). Other factors such as voltage, liquid solvent ratio, and liquid flavor will be held constant. Plasma nicotine concentration, subjective effects, and puffing behavior will be recorded for each condition.

Clinical Trial Description

Electronic cigarettes (ECIGs) are a popular and rapidly evolving class of products. ECIG users can manipulate several device features including liquid nicotine concentration (mg/ml) and heating element resistance (ohms). An emerging class of ECIG models includes "sub-Ohm" devices that employ low resistance heaters that are often used to achieve high device power. Some clinical laboratory data suggest that high power devices deliver nicotine to the user effectively, even when paired with a low liquid nicotine concentration. However, given that ECIG heater resistance and liquid nicotine concentration have not been manipulated in clinical laboratory studies, the influence of these factors on ECIG acute effects remain unclear. The purpose of this clinical laboratory study is to measure the influence of heater resistance and liquid nicotine concentration on ECIG acute effects. Participants will attend the lab for four experimental sessions where they use an ECIG. For each session, the participants will be randomly assigned (like the flip of a coin) to receive an ECIG with one of two different levels of heating coil resistance (which will determine overall device power) and one of two different liquid nicotine concentrations. The four sessions will begin at approximately the same time each day, will be separated by at least 48 hours, and will not occur more than two times per week. The primary hypotheses are that the low resistance heater paired with the 8 mg/ml liquid nicotine concentration, will result in greater nicotine delivery and subjective effect profiles, suggestive of higher abuse potential. Results from this study will further our understanding of the factors that influence the dependence potential of ECIGs and could inform future regulation of these devices. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03496116
Study type Interventional
Source Virginia Commonwealth University
Contact Marzena M Hiler, M.S.
Phone 714-512-1647
Status Recruiting
Phase N/A
Start date May 21, 2018
Completion date February 2019

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