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



Status:Completed
Conditions:Smoking Cessation, Smoking Cessation, Tobacco Consumers
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:21 - 35
Updated:3/24/2019
Start Date:May 2015
End Date:March 26, 2018

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Assessing the Use of Electronic Cigarettes (E-cigarettes) as a Harm Reduction Strategy

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.

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

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.
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