N/A
Completed N=27
Effects of Electronic Cigarettes on Nicotine Concentrations
Health Behavior
Source: ClinicalTrials.gov NCT01775787 ↗
Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcomePrimary: Effects E-cig Use on Venous Nicotine Concentrations Before and 5 Minutes After Use — 4.30; 4.11; 8.66; 8.77 ng/ml
Summary
This study will examine whether nicotine levels increase with electronic cigarettes. It will also examine whether electronic cigarettes alter lung function tests. The study will obtain preliminary data on the medical effects of electronic cigarettes, with two different nicotine flavors, tobacco and tobacco with menthol, which are available for over the counter purchase.
The electronic cigarettes and juice used in this study is available for purchase through the internet. An investigational new drug application (IND) is not needed for this study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effects E-cig Use on Venous Nicotine Concentrations Before and 5 Minutes After Use |
4.30; 4.11; 8.66; 8.77 | — |
Eligibility Criteria
Inclusion Criteria
- Smoking 10 cigarettes daily
- Agree to abstain from smoking and use electronic cigarettes for 2 weeks
Exclusion Criteria
- Unstable medical or psychiatric disorders as determined by the principal investigator
- Pregnancy
- Known hypersensitivity to nicotine or propylene glycol or menthol
- Recent M. I. or stroke
- Uncontrolled hypertension (BP.>160/100)
- Insulin dependent diabetes
- Known COPD or asthma
- Alcohol or other drug abuse or dependence
Data sourced from ClinicalTrials.gov (NCT01775787). 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.