N/A N=27 Randomized Basic Science

Effects of Electronic Cigarettes on Nicotine Concentrations

Health Behavior

Bottom Line

View on ClinicalTrials.gov: NCT01775787 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2017

Primary outcome: Primary: Effects E-cig Use on Venous Nicotine Concentrations Before and 5 Minutes After Use — 4.30; 4.11; 8.66; 8.77 ng/ml

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Nicotine with Tobacco Flavor and Tobacco & Menthol Flavor (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: UConn Health
Primary completion: Jun 2015

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	—

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.

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

View full record on ClinicalTrials.gov →

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.