Electronic Cigarettes (E-cigarettes) as a Harm Reduction Strategy

Not Applicable

Completed

• Conditions: Smoking; Tobacco Use Disorder
• Interventions: Device: e-cigarettes

• Registration Number: NCT02628964
• Lead Sponsor: NYU Langone Health

Brief Summary

The purpose of this study is to examine the feasibility of using e-cigarettes as a method for harm reduction and the effects of providing e-cigarettes (or placebo e-cigarettes) on smoking outcomes. Participants will be randomized to receive either e-cigarettes with nicotine cartridges or e-cigarettes with placebo cartridges, and followed for 3 weeks.

Detailed Description

This pilot study will be a two-arm, randomized controlled trial. The investigator will randomize 40 participants into each intervention arm. Participants will be randomized to one of the two arms: e-cigarettes with nicotine cartridges or e-cigarettes with placebo cartridges (0mg). Participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges. Participants will be asked to track their nicotine use via text message. All participants will receive a 20-30 minute behavioral counseling consultation with a trained tobacco counselor. Counselors will review each participant's smoking pattern and offer tailored behavioral and environmental change strategies including specific smoking reduction strategy options. Participants will be given a supply of e-cigarettes and followed for 3 weeks

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-09-28
• Study First Submitted QC: 2015-12-09
• Study First Posted: 2015-12-11
• Primary Completion: 2018-03-26
• Study Completion: 2018-03-26
• Results First Submitted: 2019-07-24
• Status Verified: 2020-02
• Results First Submitted QC: 2020-02-20
• Last Update Submitted: 2020-02-20
• Results First Posted: 2020-02-24
• Last Update Posted: 2020-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 21-35 years old
• daily smokers who smoke at least 10 cigarettes per day (CPD)
• interested in reducing CPDs
• able to provide consent
• Use a cell phone and are willing/able to receive and respond to daily text messages regarding their cigarette use and e-cigarette use on their cell phone
• Willing to use an e-cigarette for 3 weeks

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Exclusion Criteria

• pregnant and/or breast feeding
• currently using smoking cessation medications (including other forms of Nicotine Replacement Therapy (NRT), buproprion, or varenicline)
• enrolled in a smoking cessation program or another cessation trial
• have used an e-cigarette in the past 14 days
• have used any other tobacco products (pipe, cigar, cigarillos, snuff, chewing tobacco, rolling tobacco, or hookah/shisha) in the past 30 days
• score ≥7 (men) or ≥5 (women) on the Alcohol Use Disorders Identification Test (AUDIT-C),
• score ≥ 5 on the Drug Abuse Screening Test-10 (DAST)
• report having a history of asthma, other airways diseases, or heart disease.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4.5% e-cig	e-cigarettes	e-cigarettes with nicotine cartridges
0 mg e-cig	e-cigarettes	e-cigarettes with placebo cartridges (0mg).

Primary Outcome Measures

Name	Time	Method
Proportion of Participants Who Achieve 50% Reduction in Number of Cigarettes Per Day at 3 Weeks.	up to 3 weeks	Using the percent difference in number of cigarettes per day from baseline to 3-weeks, the proportion of participants who reduced their cigarette usage per day by 50% or greater
Changes in the Number of Cigarettes Per Day (CPD)	Baseline up to 3 weeks

Secondary Outcome Measures

Name	Time	Method
Number of Nicotine Urges/Cravings	Up to 12 weeks
Number of Participants Using Additional Tobacco Products and/or Marijuana	Up to 12 weeks
Number of Participants Experiencing Withdrawal Symptoms	Up to 12 weeks	No data displayed because Outcome Measure has zero total participants analyzed.
Percent of Participants in Each Arm Who Reported Side Effects	3 weeks	Percentage of participants who responded yes to a yes/no question about experiencing any side effects
Percentage Satisfaction Rating for the E-cigarettes	3 weeks	Percent of participants who reported either "Strongly Agree" or "Agree" to liking using e-cigarettes at 3-weeks

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States