N/A
N=234
Changes in Biomarkers Associated With Use of Electronic Cigarettes
Biomarkers
Bottom Line
View on ClinicalTrials.gov: NCT03084315 ↗Enrolled (actual)
234
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Change in Biomarker Concentrations: Nicotine Equivalents — 74.9; 79.56 mmol/mg creatinine
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- E-Cig Zero Nicotine (Device); E-Cig 24mg Nicotine (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Biomarker Concentrations: Nicotine Equivalents |
74.9; 79.56 | — |
| PRIMARY Change in Biomarker Concentrations: NNAL |
1.98; 1.95 | — |
Summary
The objective of this clinical trial was to compare the effects of e-cigarettes with and without nicotine on patterns of combustible cigarette use and biomarkers of exposure to tobacco toxicants among African American smokers.
Eligibility Criteria
Inclusion Criteria
- self-identify as African American or Black;
- age 18 years or older;
- smoke at least five cigarettes daily for the past year;
- not interested in quitting smoking in the next 6 months;
- Willing to use e-cigarettes;
- Good physical health (no unstable medical or mental health condition);
- no contraindications for e-cigarette use.
Exclusion Criteria
- Recent unstable or untreated psychiatric diagnosis including substance abuse, as determined by the DSM-IV criteria;
- use in the past 30 days of tobacco or nicotine products including e-cigarettes, other than regular cigarettes;
- participation in a smoking cessation program in the past 30 days;
- pregnant or nursing.
Data sourced from ClinicalTrials.gov (NCT03084315). 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.