NCT02500615

The Effect of Electronic Cigarette (ECIG) Liquid Vehicles on ECIG Acute Effects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study examines the acute effects in ECIG users of the two primary vehicles in ECIG liquids, propylene glycol and vegetable glycerin. Thirty experienced ECIG users will use an ECIG in five conditions that will differ only by the propylene glycol:vegetable glycerin ratio: 100:0, 70:30, 50:50, 30:70, and 0:100 (device voltage, heater resistance, liquid nicotine concentration, puff number, and interpuff interval all will be held constant). Plasma nicotine concentration, subjective effects, and puffing behaviors will be recorded in each condition.

Detailed description

Electronic cigarettes (ECIGs) are among the most important issues in public health today due to their dramatic increase in popularity. However, very little is known about ECIGs, including what factors may make them more likely to be used and abused. Examining factors that influence nicotine yield, delivery, and subjective effects from ECIGs is essential to understanding their abuse liability. Limited pre-clinical research has revealed that nicotine yield may be influenced by the ratio of the two liquid vehicles, propylene glycol (PG) and vegetable glycerin (VG), most commonly found in ECIG solutions. Specifically, higher proportions of PG result in greater nicotine yields. However, the influence of PG:VG ratio on nicotine delivery and subjective effects associated with ECIG use has not been examined previously. The primary hypotheses are that higher proportions of PG will result in greater nicotine delivery and subjective effect profiles suggestive of higher abuse liability in ECIG users. Results from this project will result in further understanding of the factors that influence the abuse liability of ECIGs and could inform regulation of these products.

Conditions

• Nicotine Exposure
• Nicotine Withdrawal Suppression

Interventions

Type	Name	Description
OTHER	ECIG liquid vehicles	The ratio of propylene glycol and vegetable glycerin will be changed while all other factors of the electronic cigarette provided to participants will be held constant.

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-05-16
• Completion: 2017-05-16
• First posted: 2015-07-16
• Last updated: 2018-05-07

Locations

1 site across 1 country: United States