Short-Term Cardiovascular Effects of E-Cigarettes: Influence of Device Power
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cardiovascular Risk Factor
- Nicotine Dependence
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: Crossover AssignmentMasking: None (Open Label)Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 21 years and 125 years
- Gender
- Both males and females
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-cigarette power. Three power levels will be assessed on all participants: 10, 35, and 70 watts. Hypothesis 1a: Systemic nicotin...
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-cigarette power. Three power levels will be assessed on all participants: 10, 35, and 70 watts. Hypothesis 1a: Systemic nicotine exposure and subjective measures of sensation in the throat, reward, and satisfaction will increase with increasing power in the e-cigarette device. Hypothesis 1b: Mercapturic acid metabolites of volatile organic compounds (VOCs), particularly acrolein, will increase with e-cigarette power. Hypothesis 1c: CV effects increase with higher power, and are manifested as changes in hemodynamic parameters, hormonal release, and biomarkers of endothelial function, platelet activation, inflammation, and oxidative stress.
Tracking Information
- NCT #
- NCT03839745
- Collaborators
- National Institutes of Health (NIH)
- Food and Drug Administration (FDA)
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Gideon St. Helen, PhD University of California, San Francisco
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