Short Term Effects of Electronic Cigarettes in Tobacco Dependent Adults

Not Applicable

Completed

• Conditions: Smoking; Nicotine Dependence
• Interventions: Other: Non-nicotine e-cigarette; Other: Nicotine e-cigarette

• Registration Number: NCT02498145
• Lead Sponsor: Yale University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-07-13
• Study First Submitted QC: 2015-07-13
• Study First Posted: 2015-07-15
• Status Verified: 2016-04
• Primary Completion: 2016-06
• Study Completion: 2016-11
• Last Update Submitted: 2017-06-28
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-nicotine e-cigarette	Non-nicotine e-cigarette	Patients will receive nicotine patch and intensive counseling plus e-cigarette without nicotine.
Nicotine e-cigarette	Nicotine e-cigarette	Patients will receive nicotine patch and intensive counseling plus e-cigarette with nicotine.

Primary Outcome Measures

Name	Time	Method
Change in daily quantitative cigarette smoking	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.
Change in exhaled carbon monoxide (CO) levels	baseline, 8 weeks, and 6 months.	Exhaled carbon monoxide levels will be measured with a precision instrument for detecting CO in exhaled breath.

Secondary Outcome Measures

Name	Time	Method
Short-term impact on lung function (spirometry)	6 months	Lung function will be measured by spirometry at time of study enrollment and at 6 months.

Trial Locations

Locations (1)

Yale-New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States