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Health Behavior | Effects of Electronic Cigarettes on Nicotine Concentrations

Health Behavior research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Health Behavior

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Study Status

Completed

Start Date: October 2012

Completed Date: June 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Effects E-cig Use on Venous Nicotine Concentrations Before and 5 Minutes After Use

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Cheryl Oncken, M.D.

Lead Sponsor: UConn Health

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01775787

Oncken CA, Litt MD, McLaughlin LD, Burki NA. Nicotine concentrations with electronic cigarette use: effects of sex and flavor. Nicotine Tob Res. 2015 Apr;17(4):473-8. doi: 10.1093/ntr/ntu232.

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