Short Term Effects of Electronic Cigarettes in Tobacco Dependent Adults

NCT02498145 | Completed

• 1 other identifier: 1407014335
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking; Nicotine Dependence

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (1)

• Short-term impact on lung function (spirometry)

  6 months

Study Arms (2)

Nicotine e-cigarette

EXPERIMENTAL

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

Other: Nicotine e-cigarette

Non-nicotine e-cigarette

ACTIVE COMPARATOR

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

Other: Non-nicotine e-cigarette

Interventions

Nicotine e-cigarette OTHER

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

Nicotine e-cigarette

Non-nicotine e-cigarette OTHER

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

Non-nicotine e-cigarette

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Smoking 1 or more tobacco cigarettes per day.
• Residence within reasonable driving distance to New Haven..

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale-New Haven Hospital

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Smoking; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Stephen R. Baldassarri, M.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2015
• First Posted: July 15, 2015
• Study Start: October 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: November 1, 2016
• Last Updated: July 2, 2017

Record last verified: 2016-04

Locations

US (1)