Effects of Electronic Cigarettes on Nicotine Concentrations

NCT ID: NCT01775787

Last Updated: 2017-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2015-06-30

Brief 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.

Detailed Description

This is a randomized two-period cross-over study in which subjects who smoke greater than 10 cigarettes will be instructed to quit smoking and use either Joye (Ego C brand) with an 18 mg cartridge containing either a tobacco or tobacco mentholated flavor for one week. Prior to starting e-cig use we will collect one blood sample for nicotine/cotinine as a measure of overall nicotine exposure. Subjects will use the device for one week and at the end of approximately one week of use, we will assess nicotine/cotinine concentrations (before and 5, 10, 15, 20 and 30 minutes after the onset of ECIG use), pulmonary function tests (before and 5 minutes after ECIG use), and subjective impressions of satisfaction. At the end of one week, subjects will be crossed over to the other condition and assessments will be repeated after another week of E-cigarette use.

A total of 30 smokers will be recruited from the surrounding areas via advertisements in newspapers and radio advertisements and University of Connecticut Health Center (UCHC) broadcast e-mail. Posters will be placed in clinical areas to recruit from physician practices. Current smokers are being proposed for three reasons: 1) we wish to determine whether nicotine levels from e-cigarettes rise to the levels of regular cigarettes when used by regular smokers; 2) we wish to determine if there are any differences seen in pulmonary function when a person switches from regular cigarettes to e-cigarettes; 3) we wish to evaluate the level of satisfaction that regular smokers have with e-cigarettes. All of these questions will have implications for later, more extensive studies of e-cigarettes, particularly in regard to their utility as a smoking cessation modality.

Once a potential study subject calls and expresses interest in the study, preliminary inclusion criteria will be assessed over the phone. Inclusion criteria include 1) at least 18 years of age; 2) current use of at least 10 cigarettes daily; 3) willing to abstain from cigarette smoking, and substitute e-cigs, for approximately 2 weeks; 4) able to read and sign a consent form; Exclusion criteria: 1) unstable medical or psychiatric disorders as determined by the principal investigator; 2) pregnancy; 3) known hypersensitivity to nicotine or propylene glycol or menthol; 4) previous myocardial infarction (M.I.) or stroke; 5) uncontrolled hypertension [Blood pressure (BP) >160/100); 6) insulin dependent diabetes; 7) known chronic obstructive pulmonary disease (COPD) or asthma.

Conditions

Health Behavior

Keywords

smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Tobacco Flavor/ Tobacco & Menthol Flavor

Subjects randomized to Tobacco Flavor group 7-10 days, then crossed over to Tobacco and Menthol Flavor for 7-10 days.

Nicotine with Tobacco Flavor and Tobacco & Menthol Flavor (18mg/mL nicotine)

Group Type: OTHER

Nicotine with Tobacco Flavor and Tobacco & Menthol Flavor

Intervention Type: DRUG

Subjects randomized to either Tobacco Flavor group for 7-10 days than crossed over to Tobacco \& Menthol Flavor for 7-10 days or Tobacco \& Menthol Flavor group for 7-10 days than crossed over to Tobacco Flavor for 7-10 days

Tobacco & Menthol Flavor/Tobacco Flavor

Subjects randomized to Tobacco and Menthol Flavor for 7-10 days,then crossed over to Tobacco Flavor for 7-10 days.

Nicotine with Tobacco Flavor and Tobacco & Menthol Flavor (18mg/mL nicotine)

Group Type: OTHER

Nicotine with Tobacco Flavor and Tobacco & Menthol Flavor

Intervention Type: DRUG

Subjects randomized to either Tobacco Flavor group for 7-10 days than crossed over to Tobacco \& Menthol Flavor for 7-10 days or Tobacco \& Menthol Flavor group for 7-10 days than crossed over to Tobacco Flavor for 7-10 days

Interventions

Nicotine with Tobacco Flavor and Tobacco & Menthol Flavor

Subjects randomized to either Tobacco Flavor group for 7-10 days than crossed over to Tobacco \& Menthol Flavor for 7-10 days or Tobacco \& Menthol Flavor group for 7-10 days than crossed over to Tobacco Flavor for 7-10 days

Intervention Type: DRUG

Other Intervention Names

Tobacco Flavor; Tobacco & Menthol Flavor; Electronic Cigarette; Nicotine

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

UConn Health

OTHER

Sponsor Role: lead

Responsible Party

Cheryl Oncken

Professor, Department of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cheryl Oncken, M.D.

Role: PRINCIPAL_INVESTIGATOR

UConn Health

Locations

University of Connecticut Health Center

Farmington, Connecticut, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 25762758 (View on PubMed)

Related Links

https://www.ncbi.nlm.nih.gov/pubmed/25762758

Nicotine concentrations with electronic cigarette use: effects of sex and flavor

Other Identifiers

ECIG 13-002-3

Identifier Type: -

Identifier Source: org_study_id