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

NYU Langone Health100 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

100

Conditions

Tobacco Use Disorder Smoking

Interventions

e-cigarettesDEVICE

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.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

New York University School of Medicine

New York, New York, United States

Outcomes

Primary Outcomes

Changes in the Number of Cigarettes Per Day (CPD)

Time frame: Baseline up to 3 weeks

Proportion of Participants Who Achieve 50% Reduction in Number of Cigarettes Per Day at 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

Time frame: up to 3 weeks

Secondary Outcomes

Percent of Participants in Each Arm Who Reported Side Effects

Percentage of participants who responded yes to a yes/no question about experiencing any side effects

Time frame: 3 weeks

Number of Participants Using Additional Tobacco Products and/or Marijuana

Time frame: Up to 12 weeks

Percentage Satisfaction Rating for the E-cigarettes

Percent of participants who reported either "Strongly Agree" or "Agree" to liking using e-cigarettes at 3-weeks

Time frame: 3 weeks

Number of Nicotine Urges/Cravings

Time frame: Up to 12 weeks

Number of Participants Experiencing Withdrawal Symptoms

No data displayed because Outcome Measure has zero total participants analyzed.

Time frame: Up to 12 weeks

Data from ClinicalTrials.gov

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