NCT04047836

Vaping High vs. Low Nicotine E-Liquid

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study will examine the effects of electronic cigarette e-liquid nicotine content in a randomized, crossover clinical and behavioral pharmacology study of experienced adult e-cigarette users (N=36). The specific aim is to determine the impact of nicotine content of e-liquid on nicotine pharmacology, systemic exposure to toxic volatile organic compounds, and short-term cardiovascular effects.

Detailed description

This is a within-subjects, crossover design of advanced electronic cigarette users in which we will examine nicotine pharmacokinetics, subjective effects, daily nicotine intake and nicotine titration, short-term cardiovascular effects, and toxicant exposure when participants are using low vs. high nicotine e-liquids. Hypothesis 1: E-cigarette users will titrate their intake of nicotine such that they will inhale fewer aerosol toxicants and suffer less harm to health when using higher vs. lower nicotine content e-liquids. Hypothesis 2: Compared to low nicotine, high nicotine e-liquid use will have similar cardiovascular effects throughout the day (due to compensatory behavioral changes), with similar effects on heart rate, blood pressure, and catecholamine release. Hypothesis 3: Exposure to volatile organic compounds (VOCs) will be lower when vaping high nicotine e-liquids compared to low nicotine e-liquids.

Conditions

• Cardiovascular Risk Factor
• Nicotine Dependence

Interventions

Type	Name	Description
OTHER	Low Nicotine E-Liquid	Participants will vape e-liquid with nicotine concentration of 3 mg/ml.
OTHER	Medium or High Nicotine E-Liquid	Participants will vape either e-liquid with nicotine concentration of 18 mg/ml or a JUUL device with JUUL pod of 59 mg/ml nicotine e-liquid.

Timeline

• Start date: 2023-06-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2019-08-07
• Last updated: 2023-08-22

Locations

2 sites across 1 country: United States