Clinical Trials Directory

Trials / Completed

CompletedNCT04449510

Short-Term Cardiovascular Effects of E-Cigarettes: Influence of E-Liquid pH

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
14 (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 short-term cardiovascular (CV) effects of e-liquid pH in a randomized, crossover clinical and behavioral pharmacology study of experienced adult e-cigarette users (N=21). The specific aim is to determine the impact of e-cigarette pH levels on nicotine pharmacology, systemic exposure to toxic volatile organic compounds (VOCs), and short-term cardiovascular effects.

Detailed description

This is a single-site, randomized, crossover study of experienced adult e-cigarette users to assess nicotine exposure, toxicant exposure, and the short-term CV effects of e-liquid pH. Three e-liquid pH conditions will be assessed on all participants: 5, 7, and 9. Hypothesis 2a: The rate of systemic nicotine absorption is inversely related to e-liquid pH and results in lower peak blood nicotine levels at higher pH. Hypothesis 2b: Heart rate acceleration will decrease and subjective measures of sensation in the throat, reward, and satisfaction will increase with increasing e-liquid pH.

Conditions

Interventions

TypeNameDescription
OTHERElectronic CigaretteE-cigarette Device: The delivery device will be a variable wattage all-in-one device with operating wattage of 7.0 - 75.0 W. The device will be set at 10 watts for the study visits.

Timeline

Start date
2021-01-04
Primary completion
2024-07-31
Completion
2024-07-31
First posted
2020-06-26
Last updated
2025-07-15

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT04449510. Inclusion in this directory is not an endorsement.