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
| Type | Name | Description |
|---|---|---|
| OTHER | Electronic Cigarette | E-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.