Overview

This trial is active, not recruiting.

Conditions smoking, nicotine dependence
Treatments nicotine e-cigarette, non-nicotine e-cigarette
Phase phase 2
Sponsor Yale University
Start date October 2014
End date June 2016
Trial size 40 participants
Trial identifier NCT02498145, 1407014335

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Arm
(Experimental)
Patients will receive nicotine patch and intensive counseling plus e-cigarette with nicotine.
nicotine e-cigarette
Patients will receive nicotine patch and intensive counseling plus e-cigarette with nicotine.
(Active Comparator)
Patients will receive nicotine patch and intensive counseling plus e-cigarette without nicotine.
non-nicotine e-cigarette
Patients will receive nicotine patch and intensive counseling plus e-cigarette without nicotine.

Primary Outcomes

Measure
Change in daily quantitative cigarette smoking
time frame: baseline, 8 weeks, and 6 months.
Change in exhaled carbon monoxide (CO) levels
time frame: baseline, 8 weeks, and 6 months.

Secondary Outcomes

Measure
Short-term impact on lung function (spirometry)
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Short Term Effects of Electronic Cigarettes in Tobacco Dependent Adults
Principal investigator Stephen R. Baldassarri, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Yale University.