Recruitment

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 AssignmentMasking: None (Open Label)Primary Purpose: Basic Science

Participation Requirements

Age
Between 21 years and 70 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-liquid pH. Three e-liquid pH conditions will be assessed on all participants: 5, 7, and 9. Hypothesis 2a: The rate of systemic ...

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.

Tracking Information

NCT #
NCT04449510
Collaborators
  • National Institutes of Health (NIH)
  • Food and Drug Administration (FDA)
  • National Cancer Institute (NCI)
  • National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Gideon St. Helen, PhD University of California, San Francisco