N/A
N=45
Effects of Electronic Cigarette Settings and Liquid Concentrations in Cigarette Smokers and Electronic Cigarette Users
Electronic Cigarettes
Bottom Line
View on ClinicalTrials.gov: NCT03710590 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Change in Plasma Nicotine — 8.68; 8.28; 9.53; 12.00 ng/ml
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ECIG Lab Session 15 watts, 10 mg nicotine (Other); ECIG Lab Session 15 watts, 15 mg nicotine (Other); ECIG Lab Session 15 watts, 30 mg nicotine (Other); ECIG Lab Session 30 watts, 10 mg nicotine (Other); ECIG Lab Session 30 watts, 15 mg nicotine (Other); ECIG Lab Session 30 watts, 30 mg nicotine (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Plasma Nicotine |
8.68; 8.28; 9.53; 12.00; 7.34; 7.17 | — |
| PRIMARY Puff Volume |
457.27; 748.34; 245.11; 503.43; 350.18; 708.62 | — |
| PRIMARY Puff Duration |
3.04; 4.37; 1.97; 2.83; 2.59; 4.02 | — |
| SECONDARY Heart Rate |
75.66; 75.01; 78.19; 79.92; 72.64; 79.09 | — |
Summary
The purpose of this research study is to find out how different types of electronic cigarettes (ECIG) settings, combined with e-liquids of differing nicotine concentrations, affect blood nicotine levels, use behavior (how users puff), and how users feel.
Eligibility Criteria
Inclusion Criteria--participants must be:
- healthy (determined by self-report)
- between the ages of 18-55
- willing to provide informed consent
- able to attend the lab and abstain from tobacco/nicotine as required and must agree to use designated products according to study protocol
Exclusion Criteria
- Women if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening.
- Individuals who weigh less than 110 pounds
Some study details about the eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.
Data sourced from ClinicalTrials.gov (NCT03710590). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.