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Completed

NCT Number: NCT02498145

Short Term Effects of Electronic Cigarettes in Tobacco Dependent Adults

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.

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Key information

Conditions

Smoking Behavior Chemically-Induced Disorders Mental Disorders Nicotine Dependence Substance-Related Disorders Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale-New Haven Hospital

New Haven, Connecticut, 06519, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nicotine E-cigarette

Other

Patients will receive nicotine patch and intensive counseling plus e-cigarette with nicotine.

Non-Nicotine E-Cigarette

Other

Patients will receive nicotine patch and intensive counseling plus e-cigarette without nicotine.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 15, 2015
Registry last updated
Jul 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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