N/A
Completed N=234
Changes in Biomarkers Associated With Use of Electronic Cigarettes
Biomarkers
Source: ClinicalTrials.gov NCT03084315 ↗
Enrolled (actual)
234
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcomePrimary: Change in Biomarker Concentrations: Nicotine Equivalents — 74.9; 79.56 mmol/mg creatinine
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.
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 | — |
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. Informational only — not medical advice.