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Short Term Effects of Electronic Cigarettes in Tobacco Dependent Adults

Primary Purpose

Smoking, Nicotine Dependence

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Nicotine e-cigarette

Non-nicotine e-cigarette

About this trial

This is an interventional other trial for Smoking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Yale-New Haven Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nicotine e-cigarette

Non-nicotine e-cigarette

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Change in exhaled carbon monoxide (CO) levels

Exhaled carbon monoxide levels will be measured with a precision instrument for detecting CO in exhaled breath.

Secondary Outcome Measures

Short-term impact on lung function (spirometry)

Lung function will be measured by spirometry at time of study enrollment and at 6 months.

Full Information

NCT ID

NCT02498145

First Posted

July 13, 2015

Last Updated

June 28, 2017

Sponsor

Yale University

1. Study Identification

Unique Protocol Identification Number

NCT02498145

Brief Title

Short Term Effects of Electronic Cigarettes in Tobacco Dependent Adults

Official Title

Short Term Effects of Electronic Cigarettes in Tobacco Dependent Adults

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

October 2014 (undefined)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Smoking, Nicotine Dependence

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nicotine e-cigarette

Arm Type

Experimental

Arm Description

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

Arm Title

Non-nicotine e-cigarette

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Nicotine e-cigarette

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Non-nicotine e-cigarette

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in daily quantitative cigarette smoking

Description

Quantitative tobacco cigarette smoking will be measured by experimenter-administered rating scale for 30 days prior to treatment through 6 month follow-up.

Time Frame

baseline, 8 weeks, and 6 months.

Title

Change in exhaled carbon monoxide (CO) levels

Description

Exhaled carbon monoxide levels will be measured with a precision instrument for detecting CO in exhaled breath.

Time Frame

baseline, 8 weeks, and 6 months.

Secondary Outcome Measure Information:

Title

Short-term impact on lung function (spirometry)

Description

Lung function will be measured by spirometry at time of study enrollment and at 6 months.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephen R. Baldassarri, M.D.

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale-New Haven Hospital

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06519

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Short Term Effects of Electronic Cigarettes in Tobacco Dependent Adults

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