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

NYU Langone Health

Status

Completed

Conditions

Tobacco Use Disorder

Smoking

Treatments

Device: e-cigarettes

Study type

Interventional

Funder types

Other

Identifiers

NCT02628964

14-01178

Details and patient eligibility

About

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.

Full 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

Enrollment

100 patients

Sex

All

Ages

21 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

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.