Short Term Effects of Electronic Cigarettes in Tobacco Dependent Adults

June 28, 2017 updated by: Yale University
This is a pilot human experimental study to evaluate whether the use of an e-cigarette affects lung function, exhaled CO levels, and quantitative tobacco cigarette consumption in active tobacco smokers. Subjects recruited from the Winchester Chest Clinic (WCC), Adult Primary Care Clinic (PCC) and the Smilow Cancer Hospital Smoking Cessation Service will be randomized to 1 of 2 groups: (1) nicotine patch and intensive counseling (standard care) plus nicotine e-cigarette; (2) nicotine patch and intensive counseling plus non-nicotine e-cigarette.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale-New Haven Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion:

  • Smoking 1 or more tobacco cigarettes per day.
  • Residence within reasonable driving distance to New Haven..

Exclusion:

  • Unstable psychiatric conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia.
  • Unstable medical conditions requiring hospitalization.
  • Acute myocardial infarction or acute cerebrovascular accident within the past 30 days.
  • Unstable angina.
  • History of allergic reactions to adhesives.
  • Women of childbearing potential who are pregnant, nursing, or not practicing effective contraception.
  • Current use of an electronic cigarette.
  • Subject unable or unwilling to complete study protocol for any reason.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nicotine e-cigarette
Patients will receive nicotine patch and intensive counseling plus e-cigarette with nicotine.
Other: Nicotine e-cigarette
Patients will receive nicotine patch and intensive counseling plus e-cigarette with nicotine.
Active Comparator: Non-nicotine e-cigarette
Patients will receive nicotine patch and intensive counseling plus e-cigarette without nicotine.
Other: Non-nicotine e-cigarette
Patients will receive nicotine patch and intensive counseling plus e-cigarette without nicotine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in daily quantitative cigarette smoking
Time Frame: baseline, 8 weeks, and 6 months.
Quantitative tobacco cigarette smoking will be measured by experimenter-administered rating scale for 30 days prior to treatment through 6 month follow-up.
baseline, 8 weeks, and 6 months.
Change in exhaled carbon monoxide (CO) levels
Time Frame: baseline, 8 weeks, and 6 months.
Exhaled carbon monoxide levels will be measured with a precision instrument for detecting CO in exhaled breath.
baseline, 8 weeks, and 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short-term impact on lung function (spirometry)
Time Frame: 6 months
Lung function will be measured by spirometry at time of study enrollment and at 6 months.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Stephen R. Baldassarri, M.D., Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

July 13, 2015

First Submitted That Met QC Criteria

July 13, 2015

First Posted (Estimate)

July 15, 2015

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 28, 2017

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1407014335

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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