Short Term Effects of Electronic Cigarettes in Tobacco Dependent Adults

Smoking Clinical Trial

Official title:

Short Term Effects of Electronic Cigarettes in Tobacco Dependent Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02498145
• Other study ID #: 1407014335
• Status: Completed
• Phase: N/A
• First received: July 13, 2015
• Last updated: June 28, 2017
• Start date: October 2014
• Est. completion date: November 2016

Study information

• Verified date: April 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nicotine Dependence
• Smoking
• Tobacco Use Disorder

Intervention

Other:
• Nicotine e-cigarette
Patients will receive nicotine patch and intensive counseling plus e-cigarette with nicotine.
• Non-nicotine e-cigarette
Patients will receive nicotine patch and intensive counseling plus e-cigarette without nicotine.

Locations

Country	Name	City	State
United States	Yale-New Haven Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in daily quantitative cigarette smoking	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.
Primary	Change in exhaled carbon monoxide (CO) levels	Exhaled carbon monoxide levels will be measured with a precision instrument for detecting CO in exhaled breath.	baseline, 8 weeks, and 6 months.
Secondary	Short-term impact on lung function (spirometry)	Lung function will be measured by spirometry at time of study enrollment and at 6 months.	6 months